NEW- FILL ® is indicated for the correction of severe skin depressions related to fat loss in the face (lipoatrophy ) in patients with human immunodeficiency virus treated with antiretrovirals.
DESCRIPTION OF MEDICAL DEVICE
NEW- FILL ® implant is an L- polylactic form of sterile non-pyrogenic suspension acid to restore from a sterile lyophilized by adding sterile water for injection (Ph. Eur .) This suspension contains microparticles L- polylactic acid , the crystalline form of polylactic acid . The L- polylactic acid is a synthetic , biocompatible and biodegradable polymer, the family of alpha -hydroxy acids .
COMPOSITION OF NEW- FILL ®
Each vial of dry powder contains : 150 mg of L- polylactic acid , 90 mg of sodium carboxymethyl cellulose , 127.5 mg of mannitol nonpyrogenic
PRESENTATION
The NEW- FILL ® lyophilisate is brought into a transparent glass vial under sterile , aseptic after sterilization by filtration , a crimped aluminum ring at one end sealed by a rubber stopper provided with a flip-off cap . The lyophilisate NEW- FILL ® is reconstituted with 5 ml of water for injection to form a sterile non-pyrogenic suspension.
INDICATIONS FOR USE
NEW- FILL ® is indicated for the correction of severe skin depressions related to fat loss in the face (lipoatrophy ) in patients with human immunodeficiency virus treated with antiretrovirals.
Injection technique : the depth of injection and the amount of NEW- FILL ® to administer vary depending on the area being treated and the desired result. Avoid overcorrection . If this occurs, massaging the affected area thoroughly to ensure an even distribution of the product.
Refer to the " INSTRUCTIONS " for additional information.
ACTION
NEW- FILL ® is injected into the deep dermis or subcutaneous layer with a needle 26 G. The narrow particle size distribution of the microparticles L- polylactic acid , a slow degradation kinetics , and a viscosity suitable for deep intradermal or subcutaneous injections , to give -FILL ® NEW its mechanical properties and its resorbability extended , allowing the implant
fill appropriately depressed areas of the skin .
CONTRAINDICATIONS
Do not use in cases of acute or chronic skin disease (infectious or inflammatory ) located at or near the area to be corrected. NEW- FILL ® should not be used in an allergic reaction to any component of this person .
WARNINGS
NEW- FILL ® should only be used in the deep dermis or subcutaneous layer. Avoid superficial injections to prevent the early onset of papules or nodules at the injection site , which may be the result of a (superficial injection , excessive amount of product , incorrect reconstitution) improper injection technique. Moreover , the massage treatment zone which ensures
regular distribution of the product, may also limit the appearance of papules or nodules.
Bottle NEW- FILL ® can be used for only one patient and one treatment session to avoid contamination. Do not re-use or re- sterilize the bottle. Discard vial immediately after use. Do not use if packaging or bottle is opened or damaged. Precautions must be taken to avoid injection into the blood vessels. Vascular occluding vessels may break and cause skin necrosis or embolization.
Do not overcorrect (or surinjecter ) default level for depression should gradually improve in a few weeks as a result of NEW- FILL ® . Do not inject into the red area of ??the lip ( vermilion ) .
Always mix the lyophilisate with WFI (Ph. Eur .)
For injecting NEW- FILL ® , use 26 G needles and sterile disposable syringes.
PRECAUTIONS
The following precautions should be observed : NEW- FILL ® should only be used by physicians controlling the correction of irregularities volume , thoroughly familiar with the product, training material on the product, and the user in its entirety .
The injection site should be cleaned with an antiseptic and be free of inflammation or infection.
As with any injection , patients on anticoagulant therapy may be at risk of hematoma or localized bleeding at the injection site.
Security NEW- FILL ® in pregnant women during breastfeeding, or in patients under 18 years has not been established.
No interaction studies NEW -FILL ® with drugs or other substances or implants have been performed .
Precautions must be taken when NEW- FILL ® is injected into areas where the skin is thin, such as peri- orbital area. An increased risk of papules and nodules in the periorbital area has been reported ( see " SIDE EFFECTS "). Refer to training materials instructions on injection techniques .
Security NEW- FILL ® in patients at risk of developing keloids or hypertrophic scarring lesions has not been established. NEW- FILL ® should not be used in patients with known or likely to develop keloids or hypertrophic scarring .
If laser treatment , chemical peeling or any other type of treatment resulting in a response in the dermis is considered after treatment with NEW- FILL ® , there is a risk of an inflammatory reaction at the injection site. This reaction is also possible if NEW- FILL ® is injected before complete healing of the skin after this treatment .
It is important to advise the patient to limit exposure of the treated area to the sun and avoid exposing it to a UV lamp , until the disappearance of the redness and swelling that may have occurred .
SIDE EFFECTS OF TREATMENT
Side effects usually associated with injections may occur: transient bleeding from the size of a needle tip or transient pain , localized redness at the injection site bruising , bruising or slight edema , disappearing in most cases 2-6 days. According to data from post- marketing and clinical studies , nodule formation was reported. Subcutaneous papules, invisible but palpable , visible nodules including periorbital nodules or indurated areas have been reported in the area of ??injection and may correspond to an overcorrection . Nodule formation is sometimes associated with inflammation or discoloration. The early occurrence of subcutaneous nodules at the injection site (within 3 to 6 weeks after treatment ) may be limited in accordance with the techniques recommended dilution and injection (see " PRECAUTIONS ").
The late occurrence of subcutaneous nodules at the injection site ( 1 to 14 months post- injection site) was reported , with sometimes extended to 2 years. Nodules or granulomas late formation in some cases disappear spontaneously or after treatment with multiple injections of corticosteroids or other similar products in lesions . Surgical excision of nodules was sometimes required when they were too big, appeared in sensitive areas (eg lower eyelid ) or persisted after other treatments .
Other rare side effects have been reported such as abscesses at the injection site , injection site infections including cellulitis ( facial ) , staphylococcal infections, late granuloma formation , allergic reaction, urticaria, injection site, hypertrophy or atrophy of the skin at the injection site , angioedema , telangiectasia , cutaneous sarcoidosis , scar, skin discoloration .
ANY SIDE EFFECTS OR COMPLAINT CONCERNING THE PRODUCT MUST BE REPORTED TO YOUR LOCAL DISTRIBUTOR (SEE INFORMATION ABOUT THAT AT THE END OF THE NOTICE ) .
INSTRUCTIONS
Refer to training materials for instructions on injection techniques .
Reconstitution before use
NEW- FILL ® is reconstituted extemporaneously as follows :
1 . Remove the flip-off cap from the vial and clean the area of removal of stopper with an antiseptic . Do not use if bottle seal or flip-off cap is damaged and contact your local distributor ( see the information on this topic provided at the end of this manual) .
2 . Take a sterile 5 ml syringe for single use ( graduated in 1/10 ml ) and a sterile 18 G needle and attach the needle to the syringe.
3 . Take 5 ml of sterile water for injection ( Ph. Eur) using the syringe.
4 . Inject slowly, at one time , 5 ml of water taken from the lyophilisate , introducing the 18 G needle into the rubber stopper of the vial.
5 . Let stand at least 2 hours to ensure complete hydration : Do not stir during this period. NEW- FILL ® can be stored in a refrigerator (2 ° C -8 ° C) or at room temperature (max. 30 ° C) during hydration .
6 . Just before injecting the product, the product should be gently agitated immediately before use. Shake until a homogeneous translucent suspension. To do this, a rotary agitator for bottle can be used . The product is ready for use. The reconstituted product should be injected
within 72 hours of reconstitution . If not used within 72 hours should be discarded (see " SPECIAL STORAGE CONDITIONS ").
7 . Just before use, clean the rubber stopper of the vial with an antiseptic and deduct the appropriate amount of suspension using a sterile disposable syringe and a second needle 18 G. Do not store reconstituted product into the syringe.
8 . Before injection, replace the 18 G needle by needle 26 G, then inject into the deep dermis or subcutaneous layer.
9 . To remove the remaining contents of the vial , repeating steps 6-8 above.
10 . Discard vial immediately after one session / after use for a single patient.
Patient Treatment
1 . A complete medical examination must be done to ensure that the treatment is appropriate . Before treatment with NEW- FILL ® , the patient should be fully informed of the indications, cons -indications, warnings, precautions , possible side effects and mode of administration of NEW- FILL ® . Each patient must be informed that the amount of NEW- FILL ® injected and the number of sessions of injections depend on the case of each patient and the severity of skin depression.
2 . Observe aseptic technique and hygiene. Clean the injection site with an antiseptic.
3 . The lyophilisate NEW- FILL ® should be reconstituted immediately before use with 5 ml of water for injection before being injected subcutaneously or intradermally . NEW- FILL ® should be injected into the deep dermis or subcutaneous layer.
Do not inject with needles below 26 G. Do not twist the needle. To maintain a homogeneous suspension of the product throughout the process, stirring intermittently into the syringe . Before the first injection , attach the needle 26 G syringe and expel a few drops
Product to remove air and check if the needle is not clogged . If the needle 26 is G or mouth fades during the injection , it may be necessary to change . If the needle becomes clogged, remove the needle , expel a small amount of product, set a new sterile needle 26 G syringe and expel a few drops of NEW- FILL ® to eliminate air and re- check if the needle is not clogged . In order to control the depth of the injection , stretch and push the skin in the direction opposite to that of the injection, in order to create a firm injection surface direction. The sterile 26 G needle bevel upwards , will be introduced into the skin at an angle of approximately 30-40 degrees , until the desired skin depth is reached. A change in tissue resistance is perceptible when the needle passes through the dermis to the subcutaneous layer . If the needle is inserted at too shallow an angle (small angle) or if the tip of the needle is not deep enough , then it will be in the mid or superficial papillary dermis , and the bevel of the needle may be visible through the skin . If product is injected too superficially, the injected area whiten immediately or slightly after the injection. If this occurs, the needle should be removed and the treated area must be gently massaged . If bleaching does not disappear, the patient should not receive further injections.
4 . During initial treatment with NEW- FILL ® , only a moderate correction must be made. Review the patient earlier than four weeks after treatment to assess if additional correction is needed. The patient should be informed , at the first meeting , the fact that additional treatment sessions may be necessary.
5 . After injection, apply ice to the treated area ( in a suitable machine avoiding direct skin contact ) to reduce swelling and / or bruising.
6 . It is important to massage the ( the ) area (s) treated (s) to distribute the product ( applying appropriate cream can reduce the friction on the surface of the skin during the massage).
7 . The patient should massage periodically ( the ) part ( s) processed ( s ) for five minutes, five times a day for five days after treatment so that the correction appears natural .
8 . After injection , NEW -FILL ® is visible imaging : ultrasound and MRI ( Magnetic Resonance Imaging ) . It is not visible by CT ( computed tomography ) or radiography.
SPECIAL STORAGE CONDITIONS
The lyophilisate NEW- FILL ® should be stored at room temperature, away from heat (maximum 30 ° C). After reconstitution , NEW -FILL ® can be stored up to 72 hours in a refrigerator ( 2 ° C- 8 ° C) or at room temperature (max. 30 ° C). Do not freeze.
IF THE BOTTLE THE SEAL OR THE DISH FLIP -OFF ARE DAMAGED , DO NOT USE AND CONTACT YOUR LOCAL DEALER (SEE INFORMATION ABOUT THAT AT THE END OF THE NOTICE ) .
After use , syringes and needles can be potentially contaminating . Therefore , handle and dispose of it according to medical practice and requirements. The last date on which this leaflet was last approved in November 2012 . This medical device has received CE Mark in 1999.
PRODUCTS SOLD ON THIS SITE ARE PARAPHAMACEUTIQUES PRODUCTS , THEY ARE SO ON SALE FREE AND DO NOT CALL ORDERS .
THIS PRODUCT IS A MEDICAL DEVICE . THIS PRODUCT DOES NOT BE RETURNED OR EXCHANGE
Careful injection of this product requires a technical medical procedure that must be completed imperatively by a physician ( doctor specializing in dermo cosmetic dermatologist , plastic surgeon ) .
Réf. : 003285