Data Sheet
RESTYLANE Lipp
Hyaluronic acid gel for injection
Composition:
Hyaluronic acid, stabilized 20 mg/ml
Phosphate buffered saline, pH 7 q.s.
Description
RESTYLANE* Lipp is a clear, transparent and viscous gel supplied in a glass syringe together with one or more 27 G needles. The product is for single use only. RESTYLANE Lipp is a unique form of stabilized non-animal, hyaluronic acid. Hyaluronic acid is a natural polysaccharide which occurs as an important structural element in the skin and in subcutaneous and connective tissues as well as in the synovial tissue and fluid. Hyaluronic acid belongs to a group of very few substances which are identical in all living organisms.
Mode of action
RESTYLANE Lipp is a filler that acts by adding volume to the tissue, thereby supporting the overlying (dermal) tissue to enhance the lips to the desired level of correction. The hyaluronic acid molecules' hydrophilic nature combined with its three-dimensional structure allows the molecules to bind water many times its own weight. The addition of water helps to maintain the overall volume of the product resulting in a longer duration. RESTYLANE Lipp is naturally integrated into the tissue and will in time undergo isovolemic degradation. The isovolemic pattern of degradation increases the water binding capacity of the gel, thus allowing RESTYLANE Lipp to maintain the overall volume during the degradation process.
Indication and usage
RESTYLANE Lipp is intended to be used for lip enhancement. It should be injected into the deep layer of the dermis and/or the superficial layer of the subcutis. The degree and duration of the correction depend on the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique. It is often advisable to combine RESTYLANE Lipp with other products from the RESTYLANE range of products.
Warning
RESTYLANE Lipp is only intended for use in the deep layer of dermis and/or superficial layer of subcutis. Do not resterilize RESTYLANE Lipp. Do not mix with other products.
Do not inject intravascularly. There is a potential risk with the procedure that the material could be inadvertently injected into blood vessels. This may rarely lead to vascular occlusion with transient impairment of vision, transient ischemia or even necrosis.
Do not use in patients with bleeding disorders or patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 2 weeks.
Precautions
Normal precautions associated with injections into the dermis and/or superficial layer of subcutis must be observed. Like any such procedure, the implantation of RESTYLANE Lipp is associated with an inherent risk of infection. RESTYLANE Lipp should not be used in or near anatomic sites where there is active skin disease, inflammation or related conditions. Patients who are using substances that may affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
Do not use RESTYLANE Lipp together with any other injectable implant, except for other products from the RESTYLANE range of products. RESTYLANE Lipp should not be injected into an area where a permanent implant has been placed. RESTYLANE Lipp should not be used for patients with unattainable expectations.
The patient should be informed that he or she should not expose the treated area to intense heat (e.g. solarium and sunbathing) or extreme cold at least until the initial swelling and redness have resolved.
If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with RESTYLANE Lipp there is a theoretical risk of eliciting an inflammatory reaction at the injection site. This also applies if RESTYLANE Lipp is administered before the skin has healed completely after such a procedure.
Use in Pregnancy and Lactation
RESTYLANE Lipp has not been tested in pregnant or breastfeeding women or in children.
Anticipated side effects
After the injection of RESTYLANE Lipp, some common injection-related reactions might occur. These reactions include erythema, swelling, pain, itching, bruising or tenderness at the implant site. Typically resolution is spontaneous within a week after injection into the lips. Additionally, temporary palpable lumpiness has been noted after the use of RESTYLANE Lipp in some patients. Gentle massage can reduce the risk for such a result.
Adverse events
Inflammatory reactions have been reported in rare cases. These reactions have consisted of redness, swelling, tenderness and induration at the implant site. These reactions may commence either shortly after injection or after a delay of 2-4 weeks and have generally been described as mild to moderate and self-limiting, with an average duration of 2 weeks. In pronounced cases a short course of oral corticosteroids may prove effective. Patients who have experienced this type of reaction should not be retreated with RESTYLANE Lipp or any other product within the RESTYLANE range of products.
The following very rare cases have been reported with RESTYLANE products:
- biopsy proven granuloma formation
- necrosis, possibly due to suboptimal injection technique requiring medical and/or surgical intervention
- persistent discolouration, possibly due to deposit of hemosiderin as a consequence of injection site bleeding. These reactions have mostly occurred after repeated injections.
Post inflammatory pigmentation changes due to deposit of melanin have been observed in clinical studies in people with dark skin (Fitzpatrick Type IV-VI).
Isolated cases of facial oedema and urticaria have also been reported but it is uncertain whether these cases are related to treatment or caused by underlying disease or concomitant medication.
One case of transient visual disturbance following intra-arterial injection into the upper half of the face has been reported.
Adverse events must be reported to the local Q-Med representative or RESTYLANE distributor.
Interactions
Treatment with RESTYLANE Lipp in combination with drugs and other devices or concomitant dermal therapies has not been evaluated in controlled clinical studies.
Assembly of needle to syringe
For safe use of RESTYLANE Lipp it is important that the needle is properly assembled to the syringe. Improper assembly may result in separation of the needle and syringe during injection.
See pictures 1 and 2.
- Grasp the narrow part of the needle shield loosely. Turn the needle shield clockwise until you feel counter pressure.
- Grasp the wider part of the needle shield firmly. Press and turn the needle shield 90° (a quarter turn). The quarter turn is necessary to lock the needle onto the syringe.
Dosage and administration
Before the treatment, the patient's suitability for the treatment and the need for pain relief should be assessed. For optimal patient comfort anaesthesia through a nerve block is recommended. The patient should be informed about the indications, expected result, contraindications, precautions, warnings and potential adverse events. The treatment site should be cleaned with a suitable antiseptic solution. RESTYLANE Lipp is administered using a thin gauge needle (up to 27 G) by injecting the material into the deep layer of the dermis and/or the superficial layer of the subcutis. Before injecting, press the rod carefully until a small droplet is visible at the tip of the needle. If RESTYLANE Lipp is injected too deeply or intramuscularly, the duration of the implant will be shorter because of a higher hyaluronic acid turnover rate. A too superficial injection may give blanching effects and bumps in the treated area. If blanching is observed, i.e. the overlying skin turns a whitish colour, the injection should be stopped at once and the area massaged until it returns to a normal colour.
The injection technique with regard to the depth of injection and the administered quantity may vary. RESTYLANE Lipp should only be injected by trained practitioners. To accentuate the lip line the linear threading technique can be used. When adding volume to either the upper or the lower lip, both the linear threading and the serial puncture technique can be used. Treatment should always be tailored and personalized for each patient.
Inject RESTYLANE Lipp while pulling the needle slowly backwards. Injection should stop just before the needle is pulled out from the skin to prevent material from leaking out from the injection site. To avoid unnecessary bleeding and swelling it is advised to inject slowly and to leave the needle in the tissue for a few extra seconds. Always consider the harmony of the face and try to keep a good balance. Look at the nose, lips and chin, and let these features guide the treatment. Do not overcorrect.
The lips should be gently massaged in order to obtain a favorable result. For each treatment site a maximum dosage of 2 ml per treatment session is recommended. If the treated area is swollen directly after the injection, melting ice can be applied on the site for a short period. After the first treatment, additional implantations of RESTYLANE Lipp may be necessary to achieve the desired level of correction. Periodic follow-up injections help sustain the desired degree of correction. A follow-up treatment before the full esthetic correction is completely diminished may be beneficial.
Note! The correct injection technique is important for the final result of the treatment. RESTYLANE Lipp is only intended to be administered by authorized personnel in accordance with local legislation. Please consult your local Q-Med representative or RESTYLANE distributor for more details about techniques and training opportunities.
The syringe, the needle and any unused material must be discarded immediately after the treatment session.
How supplied
RESTYLANE Lipp is supplied in a glass syringe with a luer-lock fitting. One or more gamma irradiation sterilized needles, 27 G x ½", are packed together with each syringe. 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 have been sterilized using moist heat. The number of units per package and the volume contained in each syringe is as stated on the outer package.
Do not use if package is damaged.
STERILE NEEDLE
Follow national, local or institutional guidelines for use and disposal of medical sharp devices. Obtain prompt
medical attention if injury occurs.
To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with
a replacement needle.
Do not reshield used needles. Recapping by hand is a hazardous practice and should be avoided.
Discard unshielded needles in approved sharps collectors.
Shelf life and storage
As indicated on package. Store up to 25° C. Protect from freezing and sunlight.
Medicine Classification
Prescription Medicine
Name and Address
Manufactured by
Q-Med AB, Seminariegatan 21, SE-752 28 Uppsala, Sweden
Phone +46(0)18 474 90 00, Fax +46(0)18 474 90 01
www.q-med.com, e-mail: info@q-med.com</P>
Sponsor
New Zealand
Pharmacy Retailing (NZ) t/a Healthcare Logistics
58 Richard Pearse Drive,
Airport Oaks
Auckland,New Zealand
(Distributor on behalf of Q-Med (Sweden) Australia Pty Ltd)
Date of Preparation
6 November 2008
Symbols on packaging
Do not use if package is damaged.
CE-marked according to MDD 93/42/EEC;
0344 is the notified body number for RESTYLANE Touch
CE-marked according to MDD 93/42/EEC;
0086 is the notified body number for the needle(s).
References
Product documentation is available at at your local Q-Med representative or RESTYLANE distributor, or on www.restylane.com
* RESTYLANE is a trademark owned by Q-Med AB.
A bar code for internal use (automated packaging) is included in the printed IFU.
Pictures included in the Instructions for Use
