Scalp Exo Plus

Description

• INOVOSENSE SCALP Exo Plus is a sterile, non-pyrogenic, low viscosity, colorless, and transparent compound containing hyaluronic acid and conditioned media. Hyaluronic acid is an effective scalp hydrator, and conditioned media contains growth factors and cytosignals. INOVOSENSE SCALP Exo Plus contains 0.3% lidocaine hydrochloride.
• Each box includes one 2 ml pre-filled disposable glass syringe and two traceable labels.

Composition

• Sodium Hyaluronate: 20 mg
• Conditioned media: 4 mg
• Lidocaine hydrochloride: 0.3 %
• Phosphate buffer q.s.: 2 ml

Indications

• INOVOSENSE SCALP Exo Plus is an injectable, biodegradable compound intended for hydrating the scalp and stimulate hair follicles in cases of follicle damage, weak and thinning hair.
• INOVOSENSE SCALP Exo Plus enhances hair follicles and improves hair quality by hydrating the scalp and stimulating the anagen growth phase. The presence of lidocaine aims to reduce pain during injection process.

Usage procedures

• Ensure the injection area is clean and sterile.
• Use a thin gauge needle (30 32).
• For injection, press the rod carefully until a small droplet is visible at the tip of the needle.
• Insert the needle at an approximate angle of 30° parallel to the scalp surface (superficial or medium 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 patients needs and physician’s assessment.

Contraindications

• Do not administer to patients with known hypersensitivity to any components including sodium hyaluronate and its derivatives, conditioned media and lidocaine.
• Do not use INOVOSENSE SCALP Exo Plus in patients with scalp inflammation or irritation, as adverse events may occur more frequently in these cases.
• Patients with skin diseases, infections (including sequelae of streptococcal infections).
• Patients with an active autoimmune disease.
• Patients taking immunosuppressive drugs or undergoing chemotherapy or radiotherapy.
• Not recommended for use during pregnancy, breastfeeding, or minors under 18 ages.

Precautions

• INOVOSENSE SCALP 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 post-treatment.
• Patients should avoid vigorous physical activity and alcohol consumption for 24 hours post-treatment.
• The response to INOVOSENSE SCALP Exo Plus is not the same in all patients.
• Patients should contact their physician if symptoms of skin disorders occur.
• Patients should avoid sun exposure, hot baths, saunas, and steam rooms for at least 3-5 days.

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 SCALP Exo Plus is a clear, colorless gel without particulates. If the contents of a syringe show signs of phase separation or appears 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 SCALP 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.