Perfectha® Subskin Lidocaine 3 X 1.0 Ml

PRODUCT DESCRIPTION

*The device is intended for use by a registered healthcare operator and is intended for use in adult patients (over 18 years of age) who are not pregnant or breastfeeding and are considered appropriate for treatment by the healthcare professional.

PERFECTHA LIDOCAINE is a sterile gel of cross-linked hyaluronic acid of non-animal origin with 0.3% (w/w) lidocaine hydrochloride. The gel is supplied in a pre-filled syringe, ready for use, single-use. Each carton contains single-use accessories to be used with the product. PERFECTHA LIDOCAINE is an implantable and absorbable dermal filler. The effects of PERFECTHA LIDOCAINE are immediately evident; how long they last depends on the volume and depth of injection, the injection technique of the healthcare operator, and the patient's lifestyle.

Treatment effects have variable duration** depending on the product variant used, injection technique by healthcare operators, the 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 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 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 range of products PERFECTHA LIDOCAINE is absorbable 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 operator (to be attached to the patient's medical 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 operator (to be attached to the patient's medical record)

INTENDED USE

The range of products PERFECTHA LIDOCAINE is absorbable 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 volume augmentation of the tissue. 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 fine wrinkles and superficial depressions, such as periorbital and perioral fine lines. It is also indicated for use in tear trough depressions via 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 lines, 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 volumizing moderate areas such as cheekbones, chin, jawline, temples, nose, and sub-orbicularis oculi (SOOF); and for lip augmentation.

PERFECTHA SUBSKIN LIDOCAINE is an injectable implant for deep subcutaneous injection into the subperiosteal plane. It is indicated for significant volume loss in areas such as cheekbones, chin, jawline, temples, forehead, back of the nose, and hands.

PRECAUTIONS FOR USE

• This product may only be administered by a registered healthcare operator in accordance
with local regulations.

CONTRAINDICATIONS
• Do not mix with other products before injection. This may alter the product's functionality 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 events from compression, which may present as discoloration, necrosis, or ulceration at the implant site or in the area supplied by the affected blood vessels; risk of ischemic events in other organs due to embolism.
• In case of superficial discoloration or blanching of the skin during treatment, the injection must be stopped immediately and the area massaged until its normal color is restored.
• Do not over-correct.
• 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.