PRODUCT DESCRIPTION
*The device is intended for use by a registered healthcare professional and is intended for use in adult patients (aged over 18 years) who are not pregnant or breastfeeding and are deemed appropriate for treatment by the healthcare professional.
PERFECTHA LIDOCAINE is a sterile gel of non-animal origin cross-linked hyaluronic acid containing 0.3% (w/w) lidocaine hydrochloride. The gel is provided in a pre-filled, ready-to-use, single-use syringe. Each carton contains single-use accessories to be used with the product supplied. PERFECTHA LIDOCAINE is an implantable and resorbable dermal filler. The effects of PERFECTHA LIDOCAINE are immediately evident; how long it lasts depends on the volume and depth of injection, the injection technique of the healthcare professional, and the patient’s lifestyle.
Effects of the treatment have variable durations** depending on the product variant used, injection technique by healthcare professionals, patient lifestyle, and metabolic rate.
**studies have shown effects lasting from 6 to 18 months depending on the variant of the product.
Lidocaine hydrochloride 0.3% (w/w) is integrated into the gel to reduce the sensation of pain during
treatment. With lidocaine integrated into the injectable implant, it is an additional anesthetic step
not required and makes the entire process much more pleasant for the patient.
Before the first session, contact your local Sinclair representative or authorized
PERFECTHA distributor for further information on injection techniques and training opportunities.
The range of products PERFECTHA LIDOCAINE is resorbable hyaluronic acid (HA) at 0.3% (w/w) gel prostheses of lidocaine hydrochloride 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 THE PERFECTHA FINELINES, DERM and DEEP LIDOCAINE BOX 1 blister 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 sterile single-use 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 for the healthcare professional (to be attached to the patient’s clinical record) PERFECTHA SUBSKIN LIDOCAINE 3 blisters each 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 sterile single-use needles 25G x 13mm (CE 0123)*
• 1 two-part traceability label for the patient and for the healthcare professional (to be attached to the patient’s clinical record)
INTENDED USE
The range of products PERFECTHA LIDOCAINE is resorbable hyaluronic acid (HA) at 0.3% (w/w) gel prostheses of lidocaine hydrochloride 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 areas of the face and hands to fill skin depressions and also for tissue volume enhancement. Lidocaine hydrochloride 0.3% (w/w) is integrated 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 perioral fine lines. It is also indicated for use in tear trough depressions by injection into the subperiosteal plane.
PERFECTHA DERM LIDOCAINE is an injectable implant for superficial subcutaneous injection. It is indicated for filling medium wrinkles and depressions, such as nasolabial folds and marionette wrinkles, for lip enhancement and scars.
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 for shaping and moderately volumizing areas such as cheekbones, chin, jawline, temples, nose, sub-orbicularis oculi fat (SOOF); and for lip enhancement.
PERFECTHA SUBSKIN LIDOCAINE is an injectable implant for deep subcutaneous injection subperiosteally. It is indicated for significant volume loss in areas such as cheekbones, chin, jawline, temples, forehead, dorsum of the nose, and hands.
PRECAUTIONS FOR USE
• This product may only be administered by a registered healthcare professional in accordance
with local regulations.
CONTRAINDICATIONS
• Do not mix with other products before injection. This may alter the functionality of the product and compromise the sterility of the gel, leading to an increased risk of infection.
• Do not inject intramuscularly or intravenously, as there is a risk of vascular compression events, which may present as discoloration, necrosis, or ulceration at the implant site or in the area perfused by the affected blood vessels; risk of ischemic events in other organs due to embolism.
• In case of superficial discoloration or whitening of the skin during treatment, injection must be stopped immediately and the area massaged until its normal color is restored.
• Do not overcorrect.
• Avoid injections in patients with known hypersensitivity to proteins, feathers, and bird egg products, as patients with known hypersensitivity to these items may also be sensitive to sodium hyaluronate.
