Cross-Linked Sodium Hyaluronate Gel
Modified Sodium Hyaluronate Gel for Injection CE Approved

Caution: General law restricts this device to sale by or on the order of a licensed physicianor properly licensed practitioner.

BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.


Device Description

Composition (every 1ml)

Sodium hyaluronate 24mg

Lidocaine hydrochloride 3mg

Phosphate buffer pH7.2 q.s.1ml


Singderm® is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogenized gel implant. It consists of modified hyaluronic acid (HA) produced by bacteria, formulated to a concentration of 24 mg/ml and 0.3% lidocaine in a physiologic buffer.

Singderm® is presented in a graduated, pre-filled, disposable syringe. Each box contains one syringe, an instruction leaflet and a set of labels in order to ensure traceability. The contents of the Singderm® syringe are sterilized by moist heat. If presense, the needles are sterilized by radiation and marked with CE0086.

 

Intended Use

Singderm® injectable gel implant is indicated for facial tissue augmentation by injection into areas in which restoration is required, including reconstructive treatment of volume loss as well as for facial morphological asymmetry.

 

Mode of Action

Singderm® is implanted to supplement the intercellular matrix and the intradermal tissue in order to restore lost anatomical structures. Its mechanism of action is based on the latest biotechnological developments in the production of injectable hyaluronic acid. The volume and the lifting capacity originate from the ability of hyaluronic acid to attract high amount of water, which is further increased by crosslinked process. The test resuts show that the product degraded a little at 12 weeks, degraded partly at 26 weeks, and almost degraded completely at 52 weeks.


METHOD OF USE & POSOLOGY

A. To Attach Needle to Syringe

STEP1: Remove tip cap

Hold syringe and pull tip cap off the syringe as shown in Figure A

STEP 2: Insert needle

Hold the syringe body and firmly insert the hub of the needle.

into the luer- lock end of the syringe.

STEP 3: Tighten the needle

Tighten the needle by turning it firmly in a clockwise direction (see Figure B) until it is seated in the proper position as shown in Figure C.

NOTE: Continue to tighten until the needle is seated in the proper position.

STEP 4: Remove the needle cap

Hold the syringe body in one hand and the needle cap in the other. Without twisting, pull in opposite directionsto remove the needle cap as shown in Figure D

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B. Physician Instructions

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Contraindications

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

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

·Singderm® contains trace amounts of lidocaine and is contraindicated for patients with a history

of allergies to such material.

 

Warnings

·The product must not be injected into blood vessels. Introduction of Singderm® 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.


Precautions for Use

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

·Patients should be limited to 20 mL of Singderm® per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established.

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

·Singderm® is to be used as supplied. Modification or use of the product outside the Directions 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 under18 years has not been established.

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

·Singderm® should be used with caution in patients on immunosuppressive therapy.

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

·After use, 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.

·Singderm® injectable gel is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe.

·If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with Singderm®, there is a possible risk of eliciting an inflammatory reaction at the indications 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.

·lf the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle.

·Athletes should be made aware that this product contains an active principle that may produce a positive result in anti-doping test.

·Medical practitioners must take into account the fact that this product contains lidocaine.

·The composition of this product is compatible with fields used for magnetic resonance imaging.


Side Effects

The patients must be informed that they are potential side effects associated with implantation 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.

·lnduration or nodules at the injection site.

·Staining or discolouration of the injection site.

·Poor effect or weak filling effect.

·Cases of necroses in the glabellar region, abscesses, granuloma and immediate or delayed hypersensitvity after hyaluronic acid injections have been reported. It is therefore advisable to take these potential risks into account.

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

·Any other undesirable side effects associated with injection of Singderm® must be reported to the distributor and/or to the manufacturer.

 

Specifications

24mg/ml  1ml, 2ml,10ml.

 

Shelf Life and Storage

Shelf life is 2 years, Store at 2°C to 30°C, DO NOT FREEZE.

Fragile.


Specifications
1ml CE 2ml CE 10ml CE
Applicable scope

Singderm® injectable gel implant is indicated for facial tissue augmentation by injection into areas in which restoration is required, including reconstructive treatment of volume loss as well as for facial morphological asymmetry.


Singderm® injectable gel implant is indicated for facial tissue augmentation by injection into areas in which restoration is required, including reconstructive treatment of volume loss as well as for facial morphological asymmetry.



Singderm® injectable gel implant is indicated for facial tissue augmentation by injection into areas in which restoration is required, including reconstructive treatment of volume loss as well as for facial morphological asymmetry.