タイトルまたは説明

1.Device Description

Composition

Hyaluronic acid               *5mg

Phosphate buffer pH7.2 q.s.      1ml

One syringe contains 1.0ml of Meibonda Meso.

Our meso injection is sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogenized gel. It consists of hyaluronic acid(HA) produced by Streptococcus equi bacteria, formulated to a concentration of *5mg/ml in a physiologic buffer.





2.Intended Use/Indications

Meibonda Meso injectable gel is indicated for injection into the superficial dermis and dermal-epidermal junction aimed at a whole new approach to skin rejuvenation for the face and neck etc.





3.Contraindications

  Meibonda Meso is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.

  Meibonda Meso contains trace amounts of gram-positivebacterial proteins and is contraindicated for patients with a history of allergies to such material.





4. WARMINGS

The product must not be injected into blood vessels. Introduction of ReNice into the vasculature may occlude the vessels and could cause infarction or embolization.

Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimple, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.

Injection procedure reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting≤7 days' duration.



5. PRECAUTIONS FOR USE

ReNice is packaged for single-patient use. Do not resterilize. Do not use if package is opened or damaged.

Based on preclinical studies, patients should be limited to *0ml of ReNice per *0kg(**0lbs) body mass per year. The safety of injecting greater amounts has not been established.

The safety and effectiveness for the treatment of anatomic regions other than the face neck, decollete and dorsum of the hands have not been established.

As with all transcutaneous procedures, hyaluronic acid implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.



B.Physician Instructions



This product is designed to be injected into the superficial dermis or the dermal-epidermal junction by an authorized medical practitioner in accordance with local applicable regulations. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling.

(2)Follow the above attaching needle to syringe steps.

(3) The injection technique may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered. A multi-puncture(nappage) technique, micro-papular(picotage) technique, linear threading technique or cross-hatching injections, or a combination of the 2 have been used to achieve optimal results.

(4) Inject ReNice applying even pressure on the plunger rod while slowly pulling the needle backward.

(5) The amount injected will depend on the areas which are to be corrected.

(6) Initial therapy consists of 2 or 3 treatments with ReNice every 4 weeks, and then a maintenance treatment should be given every 4 to 6 months.

(7) The physician should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of ReNice.



8. STORAGE CONDITIONS

Store at 0ºC to *0ºC, DO NOT FREEZE.

Protect from light.

Fragile.