PERFECTHA® DEEP Lidocaine

Description

Name:PERFECTHA® DEEP Lidocaine
Manufacturer: Sinclair
Active Substance(s): CROSS LINKED HYALURONIC ACID, LIDOCAINE
Strength: 20mg/ml HA, 3mg/ml Lidocaine
Pack Size: 1ML – 1 Pre-Filled Syringe
Package Content: 1 x 1ml Pre-Filled Syringe

PERFECTHA® DEEP Lidocaine is a sterile, injectable, resorbable dermal filler formulated with cross-linked hyaluronic acid (HA) of non-animal origin and 0.3% (w/w) lidocaine hydrochloride. Designed for subcutaneous injection, it targets deep facial lines and moderate volume enhancement, such as nasolabial folds, marionette lines, and features like the cheeks, chin, and jawline. Lidocaine ensures increased patient comfort during the procedure.

The gel offers immediate, visible results, with effects typically lasting between 6 to 18 months, depending on factors such as injection technique, depth, and patient lifestyle. It is administered exclusively by trained healthcare professionals and is suitable for adults over 18 who are not pregnant or breastfeeding.

Key Features:

• Concentration: 20 mg/ml of cross-linked hyaluronic acid with 0.3% lidocaine.
• Longevity: Clinical results may last from 6 to 18 months.
• Applications: Effective for deep folds, moderate volumisation, and lip augmentation.

This product is supplied in a 1.0 ml single-use pre-filled syringe and includes all required accessories for safe and effective administration. Each carton contains everything needed for a single treatment.

Packaging Details:

• 1 syringe (1.0 ml HA gel)
• 2 sterile needles: 27G x 13mm
• 1 two-part tracking label for record keeping

Ingredients:

• Sodium Hyaluronate (2.0% w/w)
• Lidocaine Hydrochloride (0.3% w/w)
• Sodium Chloride (0.9% w/w)
• Sodium dihydrogen phosphate (0.019% w/w)
• Disodium phosphate (0.037% w/w)
• Water for Injection (q.s. to 100%)

PERFECTHA® DEEP Lidocaine is indicated for filling deep lines and moderate contouring, including areas such as nasolabial folds, marionette lines, cheekbones, chin, jawline, temples, nose, and lips. It is strictly for subcutaneous use.

Contraindications:

• Hypersensitivity to hyaluronic acid or lidocaine
• Epilepsy, porphyria, or autoimmune disorders
• History of streptococcal disease or keloid scarring
• Presence of active infections, inflammatory skin diseases, or tumors at treatment site
• Pregnant or breastfeeding individuals
• Previous filler use of animal origin or permanent implants at the site

Side Effects:

• Common: Redness, swelling, bruising, pain, lumps, and discolouration
• Rare: Infections, granuloma, hypersensitivity, herpes reactivation, and migration
• Severe (very rare): Ischemia, necrosis, vision loss, or anaphylactic shock

The maximum recommended dose is 30 ml per 60 kg of bodyweight per full course, not to exceed 60 ml per year.

The injection must be performed by a trained healthcare professional using proper aseptic techniques and tools provided in the kit. Prior patient evaluation is necessary, and treatment should be tailored to the patient’s anatomical structure and medical history.

Administration Guidelines:

• Use 27G x 13mm needle
• Inject slowly to minimize complications (4–5 minutes per syringe)
• Limit of 3.0 ml per treatment site per session
• Massage treated area gently post-injection
• Apply ice packs to reduce swelling
• Do not reuse syringe or needle

Storage Recommendations:

• Store between 2°C and 30°C
• Do not freeze
• Protect from light
• Single-use only; discard after use

Proper storage and handling ensure the integrity and sterility of the product, crucial for safe and effective outcomes.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.