Poly-L-Lactic Acid Filler For injection

Product Name 

Poly-L-Lactic Acid Filler for Injection

Specifications

165mg/ bottle、240mg/ bottle、320mg/ bottle、405mg/ bottle

Main Structure and Description

Singderm is a dermal tissue filler, composed of poly-L-lactic acid, sodium carboxy-methylcellulose, and mannitol. It is white lyophilized powder, packed in a bottle, sealed with butyl rubber stopper and aluminum-plastic cap. It needs to be redissolved into suspension with sterile water for injection.

Indications

Singderm is used for deep dermis injection to increase the volume of depressed areas and correct moderate to severe facial wrinkles.

Principle of action

Singderm is a dermal tissue filler, which is injected into the deep dermis to fill the wrinkles. It is eventually completely degraded in the human body.

Contraindications

1. Consumers who are allergic to any constituents of Singderm are prohibited from using the product.

2. Consumers with acute or chronic skin disease in the therapeutic part, do not use the product.

3. Consumers with a history of crab foot swelling, prone to keloid or hypertrophic scar, do not use the product.

4. Consumers during pregnancy, lactation, or under the age of 18, do not use the product.

Precautions

1. Singderm can only be used in medical institutions officially approved by the authority, by personnel with clinical practice experience or relevant professional training, in strict accordance with the requirements of the product instructions.

2. Before using Singderm the consumer's medical history should be understood to determine whether the consumer is suitable for using the product. The consumer should be informed of the indications, contraindications, precautions, and adverse reactions.

3 No skin test is required before usingSingderm.

4. Before using Singderm, the injection sites should be disinfected.

5. When using Singderm, the principle of surgical aseptic operation should be observed. Irregularly aseptic operation may cause infective inflammation.

6. Singderm is a single-use product. Recycle is not permitted.lf the packaging has been opened or damaged before use, or the product has exceeded the shelf life, do not continue to use.

7. While using Singderm, if the needle is in jam feeling, change the needle;lf the needle is blocked, stop injection and replace the needle.

8. After using Singderm, exposure time of the treatment site in the sun should be reduced: Ultraviolet radiation should be avoided.

9. The laser treatment, chemical stripping skin treatment, or any other active intervention after using Singderm may lead to inflammation of the treatment site.

10. Singderm is a single use product. All the remaining items must be discarded immediately after use.

11. The safety of Singderm combined with other tissue fillers has not been established.

12. The safety of using Singderm in other parts and layers outside the indications has not been established.

13. The safety and efficacy of Singderm for consumers using immunosuppressive drugs systemic steroids, and/or consumers using anticoagulants has not been established.

14. The safety and efficacy of Singderm for consumers with connective tissue disorders bleeding disorders,or severe malnutrition has not been established.

Warnings

1. When using Singderm, it should be pressured slowly, and should not be injected into the blood vessels. If it enters the vascular system, vascular obstruction, embolism or infarction could occur.

2. When using Singderm, incorrect injection way should be avoided (such as improper redissolving, epidermal or superficial injection, excessive amount of product. etc.)in order to reduce pimples and/or nodules.

3. There is no need to over-fill wrinkled areas when using Singderm. lt takes effect after a few weeks of treatment.

Product Dosage

The dosage and number of injections will depend on the consumer's needs and the severity of the treatment site. To achieve the desired effect, multiple injections may be required.

Methods of application

1. Remove the aluminum plastic cap of the penicillin bottle, absorb the sterile water for injection (different specifications of products, the dosage of sterile water is different: 405mg/bottle: 5.0mL, 320mg/ bottle: 4.0mL, 240mg/bottle: 3.0mL,165mg/ bottle: 2.0mL) by a syringe with a sterile needle, inject the sterile water for injection into the penicillin bottle slowly. After water injection, the mixture is shaken for 1 min and stood for 30-60min to ensure complete dissolution of the lyophilized powder and removal of the bubbles.The penicillin bottle can be gently shaken before injection to evenly disperse the product.

2. After sterilizing the rubber stopper on the mouth of the syringe bottle, draw 1-3 mL of suspension into a sterile disposable syringe using a new sterile needle. Replace the sterile needle with a sterile needle no smaller than 26G, expel a small amount of suspension to eliminate air, and check the needle for clogging.

3. After disinfection of the injection site, the suspension can be injected.

4. Recommended injection method oSingderm:in order to control the injection depth, stretch/pull the skin opposite to the direction of injection to keep the injection surface flat, Using a sterile needle no smaller than 26G, enter the skin at an oblique angle o30"-40°. After reaching to the deep dermis, the needle is advanced at an angle of 10°to 20*In order to avoid the product entering blood vessel, the syringe should be withdrawn first. If blood withdrawn, the needle should be pulled out. Re-operate after replacing the needle.lf no blood withdraw, retrograde injection can be performed, which is pulling out the needle while advancing the syringe piston. After every 3 to 4 points of injection, the filling site should be massaged to evenly distribute the product.

5. Repeat steps 2-4 and inject the remaining product.

6. After treatment, all remaining items for the medical waste must be discarded immediately after use.

7. Postoperative treatment: After injection, ice packs can be used on the filling site (direct contact with the skin should be avoided) to reduce adverse reactions such as swelling and/or pain. For the first 5 days after injection, consumers should massage the filling site regularly (5 minutes each time, 5 times a day is recommended)to promote natural facial correction and reduce the occurrence of papules and/or nodules.

Adverse reactions

This product may cause adverse reactions such as pain, itching, redness, and swelling, bleeding, subcutaneous papules, and/or nodules at the injection site, which usually recover spontaneously without intervention. When the nodules are present for a long time, are large, or occur in anatomically difficult areas, topical corticosteroid injections or elective surgical removal could be used. Specification of resolution method and injection technology can reduce the incidence rate of pimples/nodules. 

Other rare adverse events include absences and infection at the injection site. lrregular aseptic operation may cause infectious inflammation. When infection occurs, using antibiotics can effectively relieve symptoms.

Adverse events that have been reported to be associated with vascular injection of soft-tissue filler are rare, including temporary or permanent visual impairment, and blindness, cerebral ischemia or hemorrhage (leading to stroke), skin necrosis, and damage to facial structures. If the consumer has an intravascular injection, or exhibits symptoms such as vision changes, stroke, skin whiter, or abnormal pain, the injection should be stopped, Any adverse reactions in the process of use can be directly feedback to the dealer or to Web:www.singclean.net and feedback to the production enterprise.

Sterilization

Electron beam radiation.

Storage and Shelf Life

Stored in 4℃~30℃environment. Shelf life is 2 years.

Version: 8.56.04.0003-A1      Issued date:2024-09-25