Hyamax^® Plus Lips is a high viscosity, sterile, colorless, transparent, viscoelastic, biodegradable, non-pyrogenic gel supplied in a disposable glass syringe.
Hyamax^® Plus Lips consists of Hyaluronan Soft Tissue Filling Gel from bio-fermentation and suspended in a physiological buffer pH7.
Hyamax^® Plus Lips is supplied in a disposable glass syringe with a Luer lock fitting. The syringe is equipped with a plunger stopper, finger grip, and plunger rod and packed in a blister together with two sterile needles.

Intended use
Hyamax^® Plus Lips is an injectable solution to treat facial rhytides, lipoatrophy, and augmentation for mid to deep dermal implantation. Hyamax^® Plus Lips corrects moderate to severe facial wrinkles and Nasolabial folds.

Indications
Hyamax^® Plus Lips is a dermal filler used for facial tissue augmentation in mid to deep derm. On average, the implants last between 9-12 months, depending on the patients’ lifestyle, depth, and injection location.

Side effects
An inflammatory reaction to Hyamax^® Plus Lips has been observed with swelling, redness, tenderness, induration, and rarely acneform papules at the injection site after the initial treatment.

Contra-Indications

• Injection into eye contours(eye circle. eyelids)
• Injection into the blood vessels
• Patients suffering from untreated epilepsy
• Pregnant or breastfeeding women
• Individuals under the age of 18
• Individuals prone to hypertrophic scarring
• Patients with known hypersensitivity to HA
• Patients suffering from porphyria
• Injection into inflamed and/or infected areas such as acne, herpes, etc
• Simultaneous laser treatment, intense pulsed light, chemical peeling, or dermabrasion
• Presence of considerable inflammatory response to surface peal
• Coagulation defects or under anti-coagulation therapy
• Overcorrection
• Individuals with unachievable expectations
• Hypersensitivity or allergic reactions have been rarely reported, including oedema, tenderness, and rarely acneform papules in the surrounding tissues. In pronounced cases, treatments have included systemic steroids, systemic antibiotics, and intravenous administrations of medications. Rare cases of granuloma formation, superficial necrosis, and urticaria have been reported with the same kind of products. Patients who have experienced this type of reaction should not have retreated.

Precautions

• The correct injection technique is crucial for the final result of the treatment.
• Individual differences will affect the final result of the treatment.
• If additional implantation of Hyamax^® Plus Lips is necessary, the minimum time interval is 2~4 weeks.
• Clean the area to be treated with alcohol or another suitable antiseptic solution.
• As with all transcutaneous procedures, Hyamax^® Plus Lips implantation carries a risk of infection.
• The safety of Hyamax^® Plus Lips safety during pregnancy, in breastfeeding females, or patients under 18 years has not been established.
• Hyamax^® Plus Lips should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.
• Hyamax^® Plus Lips should never be utilized for breast enlargement or implantation into bone, tendon, ligament, or muscle.
• Due to the lack of sufficient clinical data to profile the tolerance of Hyamax^® Plus Lips in patients with a history of past or current auto-immune disease, multiple allergies, or anaphylactic shock; Skincare professionals are strongly advised to administer this product with discretion on a case by case basis, carefully consider the nature of the disease.
• If you use aspirin, non-steroidal anti-inflammatory medications, or high doses of vitamin E supplements prior to treatment or any similar medications, be aware that these may increase bruising and bleeding at the injection site.
• It is strongly recommended not to use any make-up or touch the treated area within 12 hours after injection.
• Hyamax^® Plus Lips should be used with caution in patients on immunosuppressive therapy or using substances that reduce coagulation.
• After treatment, the patient should minimize exposure of the treated area to UV lamps, excessive sunlight, and extreme cold weather until any initial reaction is resolved.
• After treatment with Hyamax^® Plus Lips, patients should not receive laser treatment, chemical peeling, or any other procedure based on active dermal response.
• Patients with a severe allergic reaction should not receive treatments of Hyamax^® Plus Lips.
• Hyamax^® Plus Lips should not be injected too deep or too superficial.
• After injection, used syringes and needles should be handled as medical waste according to local and state requirements.
• Clinical investigation confirms that the first injection of Hyamax^® Plus Lips is safe. It is reported that repeated injection of the same kind of filler in the same region does not pose an increased risk for literature’s adverse reactions.

Warning

• Hyamax^® Plus Lips is for single use only.
• Do not use if the package is opened or damaged.
• Do not resterilize Hyamax^® Plus Lips as this may damage or alter the product.
• Do not inject intravascularly.
• Do not use Hyamax^® Plus Lips with other fillers.

Pre-treatment guidance

Before the treatment, skin care professionals should assess patients’ suitability for treatment and inform the indications, precautions, warnings, and potential side effects.
According to the depth of injection and the administered quantity, skincare professionals can use a linear threading technique, a serial puncture technique, or a combination of the two at the discretion of physicians.

Treatment procedure

• Hyamax^® Plus Lips should be used after indoor temperature balance.
• Local analgesia (ice, topical analgesics, or local infiltration, and/or nerve block with 1% lidocaine solution) is provided before treatment at the discretion of the skin care professional.
• Before injection, press the rod carefully until a tiny droplet is visible at the tip of the needle. Inject Hyamax^® Plus Lips while pulling the needle slowly backward and stop injecting just before the needle is pulled out from the skin to prevent material from leaking out from the injection site.
• Once the injection is completed, the injection site is manually massaged to allow Hyamax^® Plus Lips to conform to the contours of the adjacent tissues.
• After injection, if the treated area is swollen, patients can apply melting ice on the site for a short period.

Mode of action

After injection, Hyamax^® Plus Lips integrates into the tissue naturally and acts by adding volume to dermal tissue, thereby restoring wrinkles and folds to the desired correction.

Assembly of the needle to the syringe

It is important to assemble the needle for the safe use of Hyamax^® Plus Lips correctly.
Operation steps:

1. Unscrew the tip cap of the syringe carefully.
2. Peel sealed cover off the wider part of needle shield carefully.
3. Take a grip on the narrow part of the needle shield and mount the needle on the Luer-lock.
4. Take a firm grip on the wider part of the needle shield and turn it a quarter of a turn.
5. Pull off the needle shield to expose the needle.

Storage

Hyamax^® Plus Lips has to be stored between 2-25°C in a dry place and should be protected from sunlight, heat, and frost.