Description
PERFECTHA LIDOCAINE is a sterile gel of cross-linked hyaluronic acid of non-animal origin with 0.3% (w/w) lidocaine hydrochloride. The gel comes in a prefilled, ready-to-use, disposable syringe. Each carton contains disposable accessories for use with the supplied product. PERFECTHA LIDOCAINE is an implantable and resorbable dermal filler. The effects of PERFECTHA LIDOCAINE are immediately apparent; how long it lasts depends on the volume and depth of injection, the health care provider’s injection technique, and the patient’s lifestyle.
Treatment effects vary in duration** depending on the product variant used, injection by technical health workers, patient’s lifestyle, and metabolic rate.
**Studies have shown effects from 6 to 18 months depending on the product variant.
Lidocaine hydrochloride 0.3% (w/w) is incorporated into the gel to reduce pain sensation during
treatment. With lidocaine integrated into the injectable implant, it is an additional anesthetic step
not required and makes the whole process much more pleasant for the patient.
Before the first session, contact your local Sinclair representative or authorized PERFECTHA
distributor for more information on injection techniques and training opportunities.
The PERFECTHA LIDOCAINE product range is 0.3% (w/w) resorbable hyaluronic acid (HA) lidocaine hydrochloride gel prostheses intended for reconstructive purposes in the treatment, for example, of facial lipoatrophy, or morphological asymmetry associated with the aging process or other underlying condition.
BOX CONTENT PERFECTHA FINELINES, DERM and DEEP LIDOCAINE 1 blister containing:
– 1 disposable syringe containing 1.0 ml of cross-linked hyaluronic acid gel at a concentration of 20 mg/ml in phosphate-buffered saline and 0.3% (w/w) lidocaine hydrochloride (EC 2195)
– 2 sterile disposable needles (CE 0123)* ? 30G x 13mm for PERFECTHA FINELINES LIDOCAINE and PERFECTHA DERM LIDOCAINE ? 27G x 13mm for PERFECTHA DEEP LIDOCAINE
– 1 two-part tracking label for patient and caregiver (to be attached patient record) PERFECTHA SUBSKIN LIDOCAINE 3 blister packs each containing:
– 1 disposable syringe containing 1.0 ml of cross-linked hyaluronic acid gel at a concentration of 20 mg/ml in phosphate-buffered saline and 0.3% (w/w) lidocaine hydrochloride (EC 2195)
– 2 sterile disposable needles 25G x 13mm (CE 0123)*
– 1 two-part tracking label for patient and caregiver (to be attached patient record)
INTENDED USE.
The PERFECTHA LIDOCAINE product range is 0.3% (w/w) resorbable hyaluronic acid (HA) lidocaine hydrochloride gel prostheses intended for reconstructive purposes in the treatment, for example, of facial lipoatrophy, or morphological asymmetry associated with the aging process or other underlying condition. PERFECTHA LIDOCAINE is for intradermal and subcutaneous application and is implanted in facial and hand areas to fill skin depressions and also for tissue volume augmentation. Lidocaine hydrochloride 0.3% (w/w) is incorporated into the product to reduce the sensation of pain during treatment.
PERFECTHA FINELINES LIDOCAINE is an injectable implant for intradermal injection. It is indicated for filling superficial wrinkles and depressions, such as periorbital and peribuccal fine lines. is also indicated for use in lacrimal depressions by injection into the supraperiosteal plane.
PERFECTHA DERM LIDOCAINE is an injectable implant for superficial subcutaneous injection. is indicated for filling medium wrinkles and depressions, such as nasolabial folds and marionette wrinkles, lip enhancement, and scarring.
PERFECTHA DEEP LIDOCAINE is an injectable implant for subcutaneous injection. It is indicated for filling deep wrinkles and depressions such as nasolabial folds and marionette lines. It is also indicated to shape and volumize moderate areas such as cheekbones, chin, jawline, temples, nose, sub-orbicularis oculi fat (SOOF); and for lip augmentation.
PERFECTHA SUBSKIN LIDOCAINE is an injectable implant for deep subcutaneous supraperiosteal injection. It is indicated for significant volume loss in areas such as cheekbones, chin, jaw, temples, forehead, back of the nose, and hands.
PRECAUTIONS FOR USE
– This product may only be administered by a registered health care provider in accordance
With local regulations.
CONTRAINDICATIONS
– Do not mix with other products before injection. This can alter the functionality of the product and impair the sterility of the gel leading to an increased risk of infection.
– Do not inject intramuscularly or intravascularly, as there is a risk of vascularization compression events, which may manifest as discoloration, necrosis, or ulceration at the implant site or in the area irrigated by the affected blood vessels; risk of ischemic events in other organs due to embolism.
– In case of superficial discoloration or bleaching of the skin during treatment, the injection should be stopped immediately and the area massaged until its normal color restored.
– Do not overcorrect.
– Avoid injections in patients with known hypersensitivity to proteins, feathers, and eggs of bird products, as patients with known hypersensitivity to these items may also be sensitive to sodium hyaluronate
