PROSTROLANE INNER B 2ml: Reduction of localized fat.

Product description of PROSTROLANE INNER B 2ml

Prostrolane Inner B is a transparent gel supplied in a glass syringe.

The product is for single use only.

Prostrolane Inner B is a sterile, skin-absorbable medical device containing a complex of sodium hyaluronate (hyaluronic acid) and non-cross-linked peptides (Nonapeptide-32, Pentapeptide-43, Tripeptide-41, Octapeptide-11)

Innovative Biomimetic Peptides: these are molecules naturally present in the skin that send signals to key skin cells. For example, when collagen is damaged, they signal the cells to produce more collagen.The young body naturally produces these peptides at the right time. It is now possible to "copy" these natural biological messengers. These copies are the biomimetic peptides that replace the skin's native molecules to preserve and regenerate it. The peptides marketed by Cap actuel are excellent stimulators and therapeutic agents for treating ageing, pigmentation, alopecia, bags under the eyes, etc.

Sodium hyaluronate is a material of non-animal origin and biocompatibility. The role of sodium hyaluronate in the skin is to deliver peptide, to hydrate the skin by retaining water.

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 cellulite and delay the breakdown of sodium hyaluronate.

L'hyaluronate de sodium avec complexe peptidique est dégradable en 4 semaines.

Sodium hyaluronate with peptide complex is degradable within 4 weeks.

Each box contains two traceability labels and 1 pre-filled syringe (2 ml of Prostrolane Inner B). One to be given to the patient and one to be kept by the doctor in the patient's file

Indication of Prostrolane Inner B

is indicated for the treatment of subcutaneous tissue damage caused by chemical, physical and traumatic effects, such as softening and irregularities of the skin surface, Prostrolane is specially formulated to remove skin cellulite.

- Application area:

Face, abdomen, buttocks, back of the thighs

- Recommended volume of use:

Face: 4 ml / Area (maximum: 10 ml / zone)

Abdomen, buttocks, back of the thighs: 12 ml / zone (maximum: 20 ml / zone)

- The frequency of Prostrolane injections

1 session every 2 weeks (1 protocol = 4 ~ 6 sessions on average) (repeat the protocol if necessary)

Contraindications of Prostrolane Inner B

Prostrolane Inner_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 Inner 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 Inner 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.

• Postpone the use of Prostrolane Inner B / Inner B SE 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 Inner_B / Inner_BSE are packaged for single use only. Do not re-sterilise. Do not use if package is opened or damaged.

• Do not use Prostrolane Inner_B / Inner_BSE after the expiration date printed on the package.

• Prostrolane Inner_B / Inner_BSE should not be mixed with other products prior to device implantation.

• Do not inject into blood vessels

• Do not inject into eyelids  

Precautions for use of Prostrolane INNER 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 Inner B carries a risk of infection. Standard precautions associated with injectable materials should be followed.

• Injection of Prostrolane Inner_B / Inner_BSE filler may cause hyperpigmentation at the injection site.

• Bruising or bleeding may occur at the injection sites.

• Prostrolane Inner_B is a clear 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 Inner_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 Inner 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.