SKformula

Sodium Hyaluronate Complex Solution

Caution: Only to be administered by appropriately trained physician who are qualified or accredited in accordance with national law, and authorized by medical institution.

BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.

1.       DESCRIPTION AND COMPOSITION

The product is a sterile, biodegradable, transparent, colorless. non-pyrogenic, non-crosslinked injectable hydrogel lt consists of highly purified sodium hyaluronate of non-animal origin, derived from bacteria fermentation.

The product is formulated from non-crosslinked sodium hyaluronate (18mg/ml) and calcium hydroxyapatite (0.01%) in a physiological buffer.

The product is presented in a graduated, pre-filed, disposable syringe with a Luer-lock Tip Cap. Each box contains one syringe, an instruction leaflet and a set of labels in order to ensure trace ability. The contents of the product syringe are sterilized by moist heat.

2.       INTENDED USE

The product is intended to be used for improving the condition of the skin quality via dermal injection, such as moisturizing, shrinking pores, collagen regeneration

3.       MODE OF ACTION

The product is injected into the dermis, through the water binding ability of sodium hyaluronate to give hydration and moisturizing effects to improve the skin quality. Hydroxyapatite is a kind of bioactive substance, which can stimulate collagen regeneration. As time goes by, this product will gradually degrade in the human body, and the injection effect will gradually disappear, and the skin quality can be improved by re-injection. The effect of skin improvement depends on the characteristics of the defect being treated, the tissue stress at the injection site, and the injection technique

4.       CONTRAINDICATIONS

·  The product is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.

·  The product is contraindicated for the same area where patients already treated with temporary or permanent fillers.

·  The product contains trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.

5.       WARNINGS

·  The product must not be injected into blood vessels. Introduction of the product 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, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.

·  Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.

6.       PRECAUTIONS FOR USE

·  The product is packaged for single-patient use. Do not reuse, secondary use is possible to lead to some infectious diseases. Do not use the same needle for corrections in different anatomic districts. Do not re-sterilize. Do not use if package is opened or damaged.

·  It is recommended not to use more than 6mL for single dose.

·  As with all transcutaneous procedures, injection device carries a risk of infection. Standard precautions associated with injectable materials should be followed.

·  The product is to be used as supplied. Modification or use of the product outside the Instructions for Use may adversely impact the sterility, homogeneity, and performance of the product and it can therefore no longer be assured.

·  The safety for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.

·  The safety in patients with known susceptibility to keloid formation, hypertrophic scaring, and pigmentation disorders has not been studied.

·  The safety for the treatment of the evelids, the tear trough, the periorbital lines, the glabella and the crow's feet have not been established. Caution should be exercised in treating this part of the body.

·  The safety for mammary gland or internal genitals has not been established.

·  The safety for varices has not been established.

·  The product should be used with caution in patients on immunosuppressive therapy.

·  Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs. and warfarin) may, as with any injection, experience increased bruising or bleeding at injection sites.

·  If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with the product, there is a possible risk of eliciting an inflammatory reaction at the injection site. An inflammatory reaction is also possible if the product is administered before the skin has healed completely after such a procedure.

·  Failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the Luer-lock and needle hub connection.

·  After use, leftover product, treatment syringes and needles may be potential biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements, Discard needles in sharp collectors.

·  The product should not be mixed with other products. Treatment with the product in combination with drugs or other medical devices has not been tested.

·  Do not use the product if it does not appear to be in normal condition (as described in Description and Composition).

7.       SIDE EFFECTS

The patients must be informed that there are potential side effects associated with injection of this product, which may occur immediately or may be delayed. These include, but are not limited to:

·  Inflammatory reactions (redness, oedema， erythema, etc, which may be associated with itching or pain on pressure or both, occurring after the injection. These reactions may last for a week;

·  Haematomas;

·  Ecchymosis;

·  Infection;

·  Induration or nodules in the injection site (granuloma);

·  Staining or discolouration around the injected area;

·  Poor effect;

·  Immediate or delayed hypersensitivity;

·  Intolerance reactions;

·  Displacement of the material;

·  Numbness;

·  Allergic reactions.

Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their physician as soon as possible. The physician should use an appropriate treatment.

Serious incident associated with injection of the product should be reported to the manufacturer, distributor and the competent authority in which the user and/or patient is established.

8.       METHOD OF USE&POSOLOGY

A. To Attach Needle to Syringe (This product does not contain needle, the physician needs to prepare professional needles.)

STEP 1: Remove tip cap

Hold the syringe and unscrew the cap from the syringe.

STEP 2: Insert needle

Hold the syringe and insert the needle connector accurately into the Luer-lock of the syringe

STEP 3: Tighten the needle

Rotate the needle clockwise to tighten it, and there should be no skew or gap.

B. Physician Instructions

1.         The product is designed to be injected into the dermis by an authorized physician in accordance with local applicable regulations. As precision is essential to a successful treatment, the product must be used by physicians who have undertaken specific training in injection techniques for filling.

2.         Before starting treatment, physician should check the expiration date of the product.

3.         Before starting treatment, patients should be informed of the product's indications, contraindications, incompatibilities and potential undesirable effects.

4.         Before starting treatment, physician should collect data on the patient's medical history and evaluate whether this product is suitable for the patients.

5.         Before starting treatment, physician could evaluate whether the anaesthetic is suitable for the patients, in order to reduce any possible allergic reaction, the product does not contain any anaesthetic.

6.         The area to be treated should be disinfected thoroughly prior to the injection.

7.         Recommended needle size is 27G-32G.

8.         Follow the above steps for attaching needle to syringe, depress the plunger rod until the product flows out of the needle.

9.         Inject the product slowly using the applicable injection technique.

10.     During injection, the product can be shaped by the physician using the contralateral hand.

11.     If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle.

12.     The amount injected will depend on the areas which are to be corrected. Correct to 100% of the desired volume effect. Do not overcorrect.

13.     When injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues

14.     Patients may have mild to moderate injection-site responses, which typically resolve in a few days. If the treated area is swollen immediately after the injection, an ice pack applied to the site for a short period or an anti-inflammatory drug to the patients may be administered to the patients to reduce oedema. And appropriate creams orgels can be treated with ecchymosis or haematoma.

15.     Within the first 24 hours, patients should not apply pressure or cosmetics to the treated area, avoid strenuous exercise and alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites. After treatment for three weeks, patients should avoid surgery, cosmetic treatments (laser, hair removal) or direct exposure to sunlight and UVA-B radiation on the treated area. The injection site should not be exposed to extreme heat or cold until the adverse reactions have disappeared.

16.     The physician should instruct the patients to promptly report to her/him any evidence of problems possibly associated with the use of the product.

9.       SPECIFICATIONS

0.5mL,1mL,1.5mL,2mL,2.5mL,3mL,5mL

10.   STORAGE CONDITIONS

·  Shelf life is 2 years.

·  Store at a temperature between 2 'C to 20 °C.

·  Do not expose to sunlight.

·  Do not freeze and do not heat.

Version: 8.97.04.0003-A0

Issued date: 2024.08.22