Shine Exo Plus

Description

• INOVOSENSE SHINE Exo Plus is a sterile, non-pyrogenic, viscoelastic, colorless, and transparent compound containing hyaluronic acid and conditioned media. Hyaluronic acid is an effective skin hydrator, and conditioned media contains growth factors and cytosignals. INOVOSENSE SHINE Exo Plus contains 0.3% lidocaine hydrochloride.
• Each box includes one 2 ml pre-filled disposable glass syringe, two needles and two traceable labels for single use only. The dimensions of needles are stated on the external box.

Composition

• Cross-linked sodium hyaluronate: 20 mg
• Conditioned media: 4 mg
• Lidocaine hydrochloride: 0.3 %
• Phosphate buffer PH 7 q.s.: 2 ml

Indications

• INOVOSENSE SHINE Exo Plus is an injectable biodegradable compound intended for filling of depressions due to facial atrophic scars, skin re-hydration ,wrinkle reduction and rejuvenation.
• INOVOSENSE SHINE Exo Plus enables an increase in skin firmness and elasticity, improves complexion and radiance of the face, neck, décolletage. The presence of lidocaine aims to reduce pain during injection process.

Usage procedures

• Ensure the injection area is clean and sterile.
• For injection, press the plunger rod carefully until a
• Insert the needle at an approximate angle of 30° parallel to the skin surface (mid to deep dermis).
• The injection should be administered by applying consistent pressure to the plunger rod.
• Recommended treatment frequency: At least three sessions, with a four-week interval, depending on the patient’s needs and physician’s assessment.

Contraindications

• Do not administer to patients with hypersensitivity to any components, including sodium hyaluronate and its derivatives, conditioned media, and lidocaine.
• Patients with an active autoimmune disease.
• Patients taking NSAIDs, antiplatelet agents, anticoagulants, and immunosuppressants.
• Do not inject into areas with active inflammation or infection.
• Not recommended for use during pregnancy, breastfeeding, or minors under 18 ages.

Precautions

• INOVOSENSE SHINE Exo Plus should only be prescribed and injected by a trained physician using appropriate techniques.
• Patients should avoid touching and massaging the treated area for at least 6 hours and from applying makeup for 12 hours post-treatment.
• INOVOSENSE SHINE Exo Plus should not be used simultaneously with treatment such as laser peeling or medium depth skin peeling.
• Patients should avoid vigorous physical activity and alcohol consumption for 24 hours post-treatment.
• Patients should avoid sun exposure, hot baths, saunas, and steam rooms for at least 3-5 days post-treatment.
• Patients with a history of herpetic rashes may experience recurrent herpetic dermatitis following injection.
• INOVOSENSE SHINE Exo Plus is not recommended for patients with a history of streptococcal diseases and those prone to hypertrophic or keloid scars.
• No clinical data is available on injection of INOVOSENSE SHINE Exo Plus into areas have been previously treated with other aesthetic products or procedures.

Warnings

• Do not use disinfectants that contain quaternary ammonium salts (e.g., benzalkonium chloride) for skin preparation, as hyaluronan may precipitate in their presence.
• INOVOSENSE SHINE Exo Plus is a clear, colorless gel without particulates. If the contents of a syringe show signs of phase separation or appear cloudy, do not use it.
• Avoid intravenous injection to prevent infarction (tissue necrosis).
• Do not inject if the package is opened or damaged.
• The product is for single use only; do not re-sterilize and reuse.

Adverse effects

• Redness, swelling, edema, hematoma, itching, and mild pain may appear at the injection site. These symptoms can be relieved by applying ice to the treated area They generally disappear in a short period but may persist for up to 10 days.
• Hardening or nodules may appear at the point of , which will be resolved within a few days.
• Patients must be informed by the practitioner about possible side effects and adverse events before treatment.
• Any side effects not described above or lasting for more than one week should be reported to the practitioner by the patient. The practitioner must inform the product’s supplier as soon as possible.

Needle assembly method for syringe

• For optimal use of INOVOSENSE SHINE Exo Plus, it is important that the needle is properly connected to the syringe. See diagrams 1, 2, 3 and 4.

1. Firmly hold the glass cylinder of the syringe and the Luer-lock adaptor between the thumb and the index fingers.

2. Grasp the protective cap with the other hand and break the seal.

3. Push & Twist the needle on the syringe until a resistance is felt. Do not over-tight. Overtightening of the needle may lead to the Luer-lock moving and dislodging from the syringe.

4. Keep holding the Luer-lock and remove the sheath from the needle.

Storage

• Store between 2-8˚C. Protected from light and freezing.