Prostrolane White-B: Peptide complex and non-cross-linked hyaluronic acid for facial rejuvenation and brightening of the face including the reduction of localized spots.

Prostrolane White_B is a transparent gel supplied in a glass syringe.

The product is for single use only.

Prostrolane White_B is a sterile, skin-absorbable medical device containing a complex of sodium hyaluronate and non-cross-linked peptide (Oligopeptide-92, Ocatapeptide-11, Feruloyl Oligopeptide-33, Valprooyl Oligopeptide-33)

Sodium hyaluronate is of non-animal origin and a biocompatible material. The role of sodium hyaluronate in the skin is to deliver peptide, hydrate the skin by retaining it in water and act as a cushioning agent.

The peptide complex consists of 4 types of short-chain amino acid peptides linked by peptide bonds. The role of the peptide complex is to enhance the moisturising effect, improve the appearance of photoaged skin and delay the breakdown of sodium hyaluronate.

Sodium hyaluronate with peptide complex is degradable within 4 weeks. Each box contains 1 pre-filled syringe of 2 ml of Prostrolane White_B and two traceability labels.

Composition of Prostrolane White B

PBS (phosphate buffered saline), sodium hyaluronate (0.7%), peptide complex (oligopeptide-92, octapeptide-11, feruloyl oligo peptide-33, valprooyl oligopeptide-33)

Indication of Prostrolane White B

Prostrolane White_B is indicated for skin implantation or treatment of damaged subcutaneous tissue and wrinkles caused by chemical, physical and traumatic effects, as well as sun-damaged tissue such as spots. 

- Application area: face, neck

- Recommended volume of use: 2 ml / area (maximum: 4 ml / zone)

- Frequence: 1 session every 2 weeks (1 protocol = 2 ~ 4 sessions on average) (repeat the protocol if necessary)

Treatment procedure for Prostrolane White B

Pre-treatment guidelines:

Prior to treatment, the patient should avoid aspirin, non-steroidal anti-inflammatory drugs, St. John's wort or high doses of vitamin E supplements. These agents may increase bruising and bleeding at the treatment site.

1. It is necessary to counsel the patient and discuss the appropriate indication, risks, benefits and expected responses to Prostrolane White_B treatment. Inform the patient of the necessary precautions before starting the procedure.

2. Assess the patient's need for appropriate anaesthetic treatment to manage comfort, either topical anaesthesia, local or nerve block.

3. The patient's face should be washed with soap and water and dried with a clean towel.

Clean the area to be treated with alcohol or another suitable antiseptic solution.

4. Sterile gloves are recommended when using Prostrolane White_B.

5. Before treatment, carefully press down on the rod until a small droplet is visible at the tip.

6. Prostrolane White_B is administered using a sterilised thin needle (27G x 13 mm or 30G x 13 mm) which is sterilised. The sterilised needle is inserted at an angle of approximately 30° parallel to the length of the injection site. Prostrolane White_B must be injected into the mid to deep dermis. If Prostrolane White_B is injected too superficially, this may result in visible bumps and/or bluish discolouration.

7. Inject Prostrolane White_B by applying even pressure on the plunger rod. It is important that the injection is stopped just before the needle is withdrawn from the skin to prevent the material from escaping or getting too shallowly into the skin.

8. Correct to 100% of the desired volume effect.

Do not overcorrect. With skin deformities, the best results are obtained if the defect can be manually stretched to the point where it is eliminated. The degree and duration of correction depends on the character of the defect being treated.

9. The typical use for each treatment session is site specific as well as the severity of the wrinkles.

Or apply to the cleared skin surface, waiting for complete absorption.

10. After treatment, attach the traceability label to the patient's medical record.

Guideline for assembly of Prostrolane White B

Assembling the 27G or 30G needle (hypodermic needle) on the syringe. For safe use of Prostrolane White_B, it is important that the needle is correctly assembled. Incorrect assembly may result in separation of the needle from the syringe during injection. 

Contraindications of Prostrolane White B

Prostrolane White_B must not be used:

- in combination with a peeling, laser treatment or ultrasound,

- if the patient has a skin disorder, inflammation or infection at or near the treatment site.  

- in patients with a known hypersensitivity to hyaluronic acid, with a history of severe allergy or anaphylactic shock,

- in patients with autoimmune diseases,

- Due to possible interactions with other fillers, which have not been studied, Prostrolane White_B should not be used in sites where other fillers are present.

- during pregnancy, in nursing mothers and in children or minors under 18 years of age,

- for patients with coagulation disorders, skin colour disorders.

Warnings and side effects of Prostrolane White B

• Avoid applying to skin products other than those recommended by the doctor.

• The doctor should inform the patient of possible local reactions related to the implantation of this absorbable device.

• If an inflammatory reaction or any other adverse effect does not resolve within one week, the patient should inform the clinician immediately.

• The doctor is asked to report any significant side effects related to Prostrolane White_B to Caregen Co., Ltd. via the Website www.caregen.co.kr or via fax at + 82-31-452-3869.

• Postpone the use of Prostrolane White_B at specific sites where an active inflammatory process (skin rashes such as cysts, pimples, or hives) or infection is present until the process has been controlled.

• Prostrolane Natural_B is packaged for single use only. Do not re-sterilise. Do not use if package is opened or damaged.

• Do not use Prostrolane Natural_B after the expiration date printed on the package.

• Prostrolane Natural_B should not be mixed with other products prior to device implantation.

• Do not inject into blood vessels

• Do not inject into eyelids  

Precautions of use of Prostrolane White_B:

• If there is an allergic risk, a test should be performed before the first injection. The results of the test must be attached to the patient's medical file.

• Health professionals are encouraged to discuss any potential risks of injection with their patients prior to treatment and to ensure that patients are aware of the signs and symptoms of potential complications.

• To minimise the risk of potential complications, the product should only be used by healthcare professionals with training, experience and knowledge of the anatomy at and around the injection site.

• As with all transcutaneous procedures, the implantation of Prostrolane White_B carries a risk of infection. Standard precautions associated with injectable materials should be followed.

• Injection of Prostrolane White_B filler may cause hyperpigmentation at the injection site.

• Bruising or bleeding may occur at the injection sites.

• Prostrolane White_B is a transparent gel without particles.

In the event that the contents of a syringe show signs of separation and/or appear cloudy, do not use the syringe. Glass is subject to breaking under various unavoidable conditions. Care should be taken when handling the glass syringe and disposing of broken glass to avoid laceration or other injury.

• Prostrolane White_B should not be mixed with other products prior to device implantation. Patients should minimise exposure of the treated area to excessive sunlight, UV light and extreme cold at least until any initial swelling and redness disappears.

• After use, syringes and needles should be treated as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local and national requirements.

Storage condition of Prostrolane White_B 

Store between 2°C and 25°C. Protect from extreme temperatures. Ensure that there are no visible signs of damage to the packaging before use.