Perfectha Deep Lidocaine 1 x 1 ml
PRODUCT DESCRIPTION
*This device is intended for use by a registered healthcare professional, and also for use in adult patients (over 18 years of age) who are not pregnant or breastfeeding and are deemed appropriate for treatment by the healthcare professional.
PERFECTHA DEEP LIDOCAINE is a sterile gel of non-animal origin cross-linked hyaluronic acid at 0.3% (w/w) lidocaine hydrochloride. The gel is supplied in a pre-filled syringe, ready for use, and is single-use. Moreover, each carton contains disposable accessories to be used with the provided product. PERFECTHA LIDOCAINE is an implantable, and resorbable, dermal filler. Furthermore, the effects of PERFECTHA LIDOCAINE are immediately noticeable. The duration depends on the volume and depth of injection, the injection technique of the healthcare professional, and the patient’s lifestyle.
The duration of treatment effects may vary** depending on the product variant used, injection technique by healthcare professionals, patient’s lifestyle, and metabolic rate.
**Studies have shown effects lasting from 6 to 18 months depending on the product variant.
Included in the gel is 0.3% (w/w) lidocaine hydrochloride, to reduce the sensation of pain during treatment. With lidocaine integrated into the injectable implant, an additional anesthetic step is not required, making the entire process much more comfortable for the patient. Also, before the first session, please contact your local Sinclair representative or authorized PERFECTHA distributor for further information on injection techniques and training opportunities.
PERFECTHA LIDOCAINE product range is a 0.3% (w/w) lidocaine hydrochloride gel-filled, resorbable hyaluronic acid (HA) prostheses intended for reconstructive purposes in the treatment of, for example, facial lipoatrophy, or morphological asymmetry associated with the aging process, or other underlying conditions.
CONTENTS OF PERFECTHA FINELINES, DERM, and DEEP LIDOCAINE BOX
1 blister pack containing:
– 1 single-use 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 (CE 2195)
– 2 single-use sterile needles (CE 0123)
– 30G x 13mm for PERFECTHA FINELINES LIDOCAINE and PERFECTHA DERM LIDOCAINE
– 27G x 13mm for PERFECTHA DEEP LIDOCAINE
– 1 two-part traceability label, for the patient and the healthcare professional (to be attached to the patient’s medical record)
PERFECTHA SUBSKIN LIDOCAINE
3 blister packs containing each:
– 1 single-use 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 (CE 2195)
– 2 single-use sterile needles 25G x 13mm (CE 0123)
– 1 two-part traceability label, for the patient and the healthcare professional (to be attached to the patient’s medical record)
INTENDED USE
The PERFECTHA LIDOCAINE product range is a 0.3% (w/w) lidocaine hydrochloride gel-filled, resorbable hyaluronic acid (HA) prostheses intended for reconstructive purposes in the treatment of, for example, facial lipoatrophy, or morphological asymmetry associated with the aging process, or other underlying conditions. 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. The product includes 0.3% (w/w) lidocaine hydrochloride, to reduce the sensation of pain during treatment.
PERFECTHA FINELINES LIDOCAINE is an injectable implant for intradermal injection. It is indicated for the filling of wrinkles and superficial depressions, such as perioral and peribuccal fine lines. It is also indicated for use in tear troughs, by injection into the supraperiosteal plane.
PERFECTHA DERM LIDOCAINE is an injectable implant for superficial subcutaneous injection. It is indicated for the filling of medium wrinkles and depressions, such as nasolabial folds and marionette lines, for lip enhancement, and for scar improvement.
PERFECTHA DEEP LIDOCAINE is an injectable implant for subcutaneous injection. It is indicated for the filling of deep wrinkles and depressions such as nasolabial folds and marionette lines. It is also indicated for shaping and volumizing moderate areas such as cheeks,chin, and jawline.
PERFECTHA SUBSKIN LIDOCAINE is an injectable implant for deep subcutaneous and supraperiosteal injection. It is indicated for deep tissue augmentation, such as the correction of deep wrinkles and folds, chin and cheek contouring, and facial volume restoration.
IMPORTANT SAFETY INFORMATION
– PERFECTHA LIDOCAINE should only be administered by a trained and qualified healthcare professional.
– The product should not be used in patients with a known hypersensitivity to hyaluronic acid or lidocaine or in the presence of any active skin infection in or near the treatment area.
– Injection-related reactions such as redness, swelling, pain, itching, discoloration, and tenderness at the injection site may occur. These reactions are usually mild to moderate and typically resolve spontaneously within a week after injection.
– Serious adverse events, including vascular occlusion and necrosis, have been reported following the use of dermal fillers. The healthcare professional should be familiar with the anatomy and techniques for the procedure and be aware of the signs and symptoms associated with vascular compromise and take appropriate action.
– Patients should avoid exposure to excessive heat, cold, or sun and avoid strenuous exercise or facial massages for the first 24 hours after treatment.
– The safety and effectiveness of PERFECTHA LIDOCAINE in pregnant or breastfeeding women, individuals under 18 years of age, and patients with a history of autoimmune diseases or bleeding disorders have not been established.
This is just a brief overview of the product and its intended use. It is important to consult with a healthcare professional for a comprehensive understanding of the product, its indications, contraindications, and potential risks.
