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  » Dermal fillers  »   Amazing fill Injection Hyaluronic acid Gel
Amazing Fill
Product Information
Before & After Pictures
Anticipated side-effects
FAQ
Instructions for Use
ISO Certificates
Scientific Studies

Amazing Fill

What is AMAZING FILL?

AMAZING FILL TM is a crystal-clear, biodegradable NASHA (Non-Animal Stabilized Hyaluronic Acid) gel, which is injected into the dermis in tiny amounts with a very fine needle. The result is instantaneous, producing a long-lasting, natural enhancement, gentle and safe to the skin. Since it was launched in 1996, DPSHA has undergone extensive histological and clinical studies with an increasing body of evidence relating to its ease of use, tolerability and effectiveness. Today, more than one million treatments have been successfully carried out worldwide. AMAZING FILL is approved by Chinese FDA (SDA). The quality control is in accordance with the International quality standards of ISO9002 and ISO13488.

What is AMAZING FILL used for?

Facial wrinkles Removing

For the treatment of wrinkles or folds, AMAZING FILL is injected into the skin in small amounts with a very fine needle. The injected gel gives natural volume under the wrinkle, which is lifted up and smoothed out. The results can be seen immediately. Treating wrinkles with AMAZING FILL is fast and safe ¨C and leaves no scars or other traces on the face.

Lips enhancement

Lip augmentation is usually carried out in two steps ¨C pouting and contouring. To create a more pronounced mouth and fuller lips, AMAZING FILL is injected into the upper and/or lower lip. This is often combined with the marking of the vermilion border by injecting the gel along the lip line. Redefining this edge leads to a more youthful and appealing look. The philtrum ridges can be defined by injecting the gel into the lines. To achieve the optimal result, a combination of these steps is often used.

Facial contouring

Injected into the skin, AMAZING FILL corrects deep folds and lifts up the skin from the cheeks, temple and chin, giving a new shape to the facial contours.

Product Information

In its native form, hyaluronic acid is degraded very quickly. In order to maintain a volume-augmenting effect in the tissue over a longer period of time, the hyaluronic acid in AMAZING FILL has been stabilized. Each product in the AMAZING FILL product range contains the same high concentration of stabilized hyaluronic acid: 20 mg per ml. Without stabilization, hyaluronic acid remains in the tissue for only a few days before it is degraded. Conversely, too much modification can adversely affect its biocompatibility. The NASHA gel in AMAZING FILL is only stabilized by approximately 1%. This provides longer-lasting effects with minimal tissue disturbance. After injection, the hyaluronic acid in AMAZING FILL attracts water and the effect generally remains for 6 - 12 months.

Fully biocompatible

Hyaluronic acid in itself is fully biocompatible. The question of the biocompatibility of hyaluronic acid products is therefore only related to the amount and type of impurities in the product. The biocompatibility of the NASHA gel in AMAZING FILL has been extensively tested both in vitro and in vivo . Nutritive agents, such as glucose and oxygen, as well as growth factors and hormones are able to pass freely between the gel particles in AMAZING FILL, leaving a healthy-looking skin during the entire residence period.

Biodegradable

The extremely effective stabilization method of the hyaluronic acid in AMAZING FILL makes it possible to maintain more volume with less material over a longer period of time. As the NASHA gel degrades, each molecule progressively binds more water (more free water-binding sites per molecule). This is known as isovolaemic degradation. In practical terms, it means that the volume is maintained until the hyaluronic acid is almost fully degraded. As the body has its own system for absorbing hyaluronic acid, it disappears over time without a trace.

Safe

One major benefit of hyaluronic acid is that it is chemically identical in all living organisms and thus has no immunological properties. AMAZING FILL contains only minimally modified hyaluronic acid, and it is very safe. There are no contraindications to the use of AMAZING FILL products and the precautions are mainly those that should be observed for any intradermal injection. Local tolerance of AMAZING FILL is excellent, as the material integrates with local tissues. Degraded material is metabolized and excreted by the same pathways as natural hyaluronic acid. Adverse events are very rare. Transient reactions, which are thought to be of a hypersensitivity nature, have been reported in about one in every 2,000 patients. Other types of reactions are even more rare. 

Non-allergic

The ingredients are non-allergic to human body. Animal tests and clinic studies proved that our hyaluronic acid filler will not cause any allergic reactions of the body.


Before & After Pictures

before
after
before
after

Anticipated side-effects

After the injection, some common injection-related reactions may occur. These include erythema, swelling, pain, itching, discoloration or tenderness at the implant site. Typically, resolution is spontaneous within a few days after injection into the skin and within a week after injection into the lips.

Adverse reactions

Reactions thought to be of a hypersensitivity nature have been reported in about one in every 2,000 treatments. They have consisted of swelling and induration at the implant site, sometimes with oedema in the surrounding tissues. Redness, tenderness and, rarely, acneform papules may also occur. These reactions have started either shortly after injection or after a delay of two to four weeks and have generally been described as mild to moderate and self-limiting, with an average duration of two weeks. In pronounced cases, a short course of oral corticosteroids may prove effective. In addition, rare cases (fewer than one in 15,000 treatments) of granuloma formation, superficial necrosis and urticaria have been reported

Quality control:

  • ISO 9002
  • ISO13488
  • Scientific studies
  • Clinic applications
  • Safety test
  • Stability test
  • Allergic and hemolysis test

FAQ

1. What is the ingredients?

All AMAZING FILL products consist of stabilized hyaluronic acid 20 mg/ml and physiological sodium chloride solution, pH 7 q.s. They are clear, transparent, viscous gels supplied in disposable syringes.

2. What is the molecular weight of the AMAZING FILL products?

The molecular weight of a AMAZING FILL gel particle 15 million to 30 million.

3. How is AMAZING FILL products sterilized?

AMAZING FILL products are steam-sterilized for maximum safety. AMAZING FILL has a sterility assurance level (SAL) of < 10-6. This method is superior to aseptic manufacturing and results in a product where the probability of finding a syringe containing a micro-organism is less than one in one million units.

4. Do AMAZING FILL products expand after injection?

Because the tissue pressure is sometimes disturbed and takes on a higher value, e.g. in connection with oedema, or a lower value, during low water intake, a small, yet significant, change (swelling or shrinkage) may occur.

5. Does AMAZING FILL get stiffer, in the lips, for example, in cold weather?

The patient should not expose the treated area to intense heat (strong sunlight) or extreme cold for the first few days after treatment in order to avoid the risk of inflammation following disturbance of the area by the injection procedure. However, once AMAZING FILL is integrated into the body, it will adjust to normal body temperature.

6. The storage condition?

The products should be stored at 2~25°C.

7. Can AMAZING FILL products be combined with other implants?

AMAZING FILL should not be used together with any other injectable implant. The products should not be injected into an area where a permanent implant has been placed.

8. Is there a need for overcorrection?

No.

9. Are there any side-effects or adverse reactions ?

Yes. After the injection, some common injection-related reactions might may occur. They include erythema, swelling, pain, itching, bruising and tenderness at the implant site. These reactions have generally been described as mild to moderate and typically resolve spontaneously a few days after injection. Reactions thought to be of a hypersensitivity nature have been reported in about one in every 2,000 treated patients. In rare instances, granuloma or abscess formation, localized necrosis and urticaria have been reported. For more information, see the instructions for use included in each product pack.

10. Can AMAZING FILL products be used for patients during pregnancy or lactation?

Treatment with AMAZING FILL during pregnancy or lactation is not recommended.

11. Are there any known interactions with antibiotics?

Treatment with AMAZING FILL products in combination with other drugs and devices has not been tested. Theoretically, there is no basis for any interaction with commonly used antibiotics.

12. How long does the effect of a AMAZING FILL treatment of lines, wrinkles and folds last?

In general, follow-up treatment is required after 6 - 12 months. Clinical trials show that AMAZING FILL is effective for up to one year after the treatment of wrinkles. However, the duration of treatment often depends on many factors, such as the structure of the skin, lifestyle and age, degree of perfection demanded by the patient and the injection technique. Clinical experience indicates that touch-up and follow-up treatments will add to the duration.

13. How long does the effect of a AMAZING FILL treatment of lips last?

It has been shown in clinical trials that AMAZING FILL is effective for up to six months. Clinical experience indicates that touch-up and follow-up treatments add to the duration. After the products disappear in the body, second injection should be performed.


Instructions for Use

MEDICAL SODIUM HYALURONATE (used for cosmetic & aesthetic surgery)


[Commodity and Constructive Formula]

Product name: Medical Sodium Hyaluronate

Chemical name: [-3] –2 acetamido –2- deoxy -ß-D-glucopyranosyl-(1 4)-ß-D- glucopyranosyluronic acid-(1 )n
Molecular formula: (C14H20NNaO11)n
Average molecular weight: =1.6×106 Dalton
Constructive formula:

[Main Ingredient]

The content of medical sodium hyaluronate=10mg/ml.PBS

[Description]

This product is colorless, odorless, transparent and high viscous, aqueous gel,
PH=6.8~7.5

[Application Range]

1) Face Contouring (Correcting hollow cheeks and improving chin)
2) Removing facial wrinkles (forehead wrinkles, crow's feet, glabellar lines, periorbital lines, oral commissures, nasolabia folds, etc.)
3) Lips enhancement
4) Treating Neck Lines.

[Product Advantages]

Good biocompatible; sterile, pyrogen-free; longer biodegrade time; low-temperature storage, good stability; mini-size, safety and efficacy; no skin test needed.

[Administration and Dosage]

1) The treated area must be washed with soap and water, and then be sterilized with ethyl alcohol. Be sure to inject under sterile condition.
2) Every syringe can be used only for one time. The injection site (in the dermis or the subcutis), range, depth and dosage must be obeyed with doctor.
3) The needle sizes used for injection can be 27G, 30G, 31G.
27G: for deep folds, facial contours and lip enhancement. Injected in the deep layer of the dermis and /or the surface layer of the subcutis.
30G: for moderate wrinkles and lip enhancement. Injected in the middle part of the dermis.
31G: for the correction of very thin superficial lines. Injected in the upper part of the dermis.
4) Keep the product in normal temperature for 30 minutes before injection.
[Side Effects] Some common injection-related reactions might occur, such as transient erythema, swelling, pain, itching, discoloration or tenderness at the injection site.

[Contraindications]

  • Acute systemic or joints inflammation
  • Pregnant women or women during lactation
  • Hypohepatia patients or with a history of analogous affection
  • Patients allergic to this product

[Cautions]

1) Avoid touching the treated area within 6 hours after injection. After that, a light makeup can be applied and the area can be gently washed with soap and water.
2) Until the initial swelling and redness have resolved, do not expose the treated area to intense heat (e.g. solarium and sunbathing) or extreme cold.
3) If you have previously suffered from facial cold sores, there is a risk that the needle punctures could contribute to another eruption of cold sores.
4) If you are using aspirin or any similar medication, be aware that these may increase the bruising and bleeding at the injection site.

[Packing]

1.0ml/syringe ( = 1.0%SHA)

[Storage]

Be stored at 2?~8?, kept away from light, and sure of no freezing.

[package]

One syringe in each box.

[Shelf Period]

Two years

[Approval Code Number]

SDA Xie Zhun Zi 2000 No.366095

ISO Certificates

Certificate of Quality Management System for Medical Devices Certificate of Product Certification for Medical Devices

Scientific Studies

1. Allergic Test for Sodium Hyaluronate
2. Hemolysis Test for Medical Hyaluronic Acid
3. Local Toxicity test For HA Injection
Allergic Test for Sodium Hyaluronate

In order to test the allergic reaction of the HA samples, guinea pigs were used for test.

1. animal.

Five guinea pigs weighed between 285g and 325g, average weight 316g.

2. test sample.

This product is a gel which is transparent, high molecule weight, highly viscous and elastic. No turbidness exists. 0.5ml/vial which contains 5mg HA.

3. Method.

1) Take one HA sample and open the vial. Add 1.5ml injection saline and mix evenly. Take care of sterility.
2) 0.2ml such HA solution (containing 0.5mg HA which was 30 times that of human dosage) was injected into the abdominal cavity. Inject every two days for three times. Another 0.4ml was injected on the 14th day.
3) Results and judge standard.
(1) No allergic reactions should be found within 15 minutes after each injection.
(2) The following reactions should be seen as allergic reaction:
One or two phenomena of Hair erection, Dyspnea, Sneeze, keck, cough for three times, or one phenomena of rale, twitch, prostration and death.

HA allergic test for guinea pigs

4. Test results

After every 0.2ml HA solution (containg 0.5mg HA) injection in the abdominal cavity and 0.4ml injection on the 14th day, within 15 minutes after injection all five guinea pigs were normal, not any positive phenomena was found.
The allergic reaction was negative.

5. Conclusion.

After 4 repeated allergic reaction tests on the guinea pigs, the injection dosage was about 30 times the human dosage, no allergic reactions were found. This proved that this product causes no allergic reactions. It's safe and is in accordance with medical standards.

Reference:
1. Chinese Pharmacopoeia, 1990, second part, P. 85
2. Shi Xinqiu, et al. Medical Animal Test Method. People's Health Publishing House, 1983.

Hemolysis Test for Medical Hyaluronic Acid

1. solvent

1) 0.2mol/L HCl
2) 3.8% sodium citrate solution: 3.8gsodium citrate in 100ml water.
3) Deactivated healthy human serum: take serum of healthy human to put in 56°C water for 30 minutes.

2. Test procedure

1) preparation of anticoagulant blood: cannula blood from Shanghai Central Blood Station was added with 20%sodium citrate solution.
2) Take 6 test tubes, then add separately 0.1ml anticoagulant blood, 0.5ml 56°C Deactivated healthy human serum, 0.2mol/L HCl 0.05ml.
3) Take 3 test tubes to add 0.05ml medical sodium hyaluronate. Then take 3 control test tubes to add 0.05ml saline and mix evenly.
4) Dip in 37°C water for one hour
5) Centrifugal

3. Result judgement

After centrifugal the upper clean fluid is the same as the sample tube, no hemolysis found.

4. Results.

10 batches of sodium hyaluronate were tested, without hemolysis.

Table 3. Results of Hemolysis test for medical sodium hyaluronate

Lot. No. Test group Control group
1 2 3 1 2 3
94-01-01 -- -- -- -- -- --
94-01-02 -- -- -- -- -- --
94-02-01 -- -- -- -- -- --
94-02-02 -- -- -- -- -- --
94-02-03 -- -- -- -- -- --
94-03-01 -- -- -- -- -- --
94-03-02 -- -- -- -- -- --
94-03-03 -- -- -- -- -- --
94-04-01 -- -- -- -- -- --
94-04-02 -- -- -- -- -- --

Because all the 10 tested samples had no hemolysis, this indicated that this product will cause no hemolysis. And 290 cases of clinic application also did not find hemolysis, thus hemolysis test was not listed in this standard.


Local Toxicity test For HA Injection

Material and Method

1. Animal

1). 20 rabbits weighed from 2-3kg

2. Test procedures

1). HA injection: HA material was dissolved in saline to make 10mg/ml injection solution;
2). The test animals were injected barbiturate sodium 30mg/kg via vein to perform systematic anesthesia, and 1%dicaine for local anesthesia. Then 2% mercurochrome and saline were used to wash the conjunctiva sac.
3). 1.5mm wide scalpel was used to make a 1mm long and 2.3 thick incision 0.5mm away from the cornea edge.
4). A 1ml syringe with NO. 5 needle was used to inject into the anterior chamber via this incision, to take out 0.2ml aqueous humor,and then inject 0.2ml HA or saline;
5) The incision of the cornea healed naturally, then 0.3% gentamycin eyedrop was dropped. Then the rabbits were fed in separate cages.

3. observation method

1). Observation time: 12h, 24h, 36h, 3d, 5d, 7d, 1m, 2m and 3m after surgery
2). Observation contents:
(1). Ultrasonic type A was used to measure the depth of theanterior chamber, and the distance from the cornea endodermis vertex to the lens anterior pole?
(2). The eye pressure was measured with ophthalmotonometer?
(3) cranny light was used to check the congestion degree of the conjunctiva, transparency of the cornea, the reactions of the iris (iris congestion, conglutination, deposition behind the cornea),lens transparency, exudation of the anterior chamber?
(4). Eyeground scope was used to check the eyeground, to check whether there are any infections or irritations.
(5). Pathological section was made to observe the pathological changes.

Conclusion

1. No significant irritation reaction was found. No infection or other abnormities were found inside the eyes. The local redness around the surgical incision was mechanical injury, and all disappeared within three days.

2. No deposition behind the cornea or iris conglutination were found. The lens and vitreous bodies were all transparent. This indicated that this product is sterile and will cause no infection.

3. In the HA and BSS (positive control) group, the eye pressure increased slightly 24 hours after injection, and gradually recovered to be the preoperative level. During operation this product had a limited time staying in the eyes, and after operation all was washed and cleared. Generally it will not cause continuously increase of eye pressure. If the injection amount is controlled, or protective treatment is performed, that is, oral administration of acetazolamide can prevent the continuously increase of eye pressure.

4. In the HA and BSS (positive control) group, there were slight iris congestion and anterior chamberexudation which were absorbed within 24 hours. The saline group (negative control) also had slight conjunctiva congestion, iris congestion and anterior chamberexudation. The absorption time was similar to that of the HA and BSS group. Within three days all disappeared. This indicated that this was caused by mechanical injury of incision.

5. This product will not cause bad irritation for the eye tissues. It's sterile, non-toxic, and no cause infection.