Bellarti (Implant) Instructions for Use

Therapeutic Category

A medical device for increasing skin hydration and elasticity.

Properties

The implant is a gel for replenishing hyaluronic acid losses associated with age-related changes.

The main component of the medical device is hyaluronic acid, which is a natural polysaccharide of the human body. Hyaluronic acid has the property of binding and retaining water for a long time at the injection site. Thereby, it both moisturizes the skin and creates a viscous elastic environment, holding the main components of the connective tissue in the correct position. The gel with hyaluronic acid is injected into the base of each wrinkle using a syringe, thus creating a depot of hyaluronic acid. This depot, on the one hand, acts as a padding material that smoothes wrinkles, and on the other hand, intensive skin hydration and improvement of its appearance occurs. Hyaluronic acid promotes the restoration of connective and epithelial tissues, normalization of pH balance. The functional advantage of hyaluronic acid is the rehydration of damaged cells and the saturation of biological fluids.

Sodium hyaluronate is obtained by fermentation of Streptococcus equi bacteria and is thoroughly purified.

Medical devices in which hyaluronic acid is combined with mannitol or with glycerol are used.

Mannitol, when combined with sodium hyaluronate, forms a more stable molecule, protecting it from breakdown, thereby prolonging the residence time of the implant in the tissues, allowing to slow down the natural process of hyaluronic acid degradation, which contributes to a long-lasting effect from the procedure. In addition, Mannitol prevents the appearance of edema after injections and significantly reduces the recovery process. Due to the formation of intermolecular Sodium hyaluronate-Mannitol bonds, it increases the antioxidant properties of the skin, stops inflammatory and degenerative processes in skin cells, exerting a rejuvenating effect, and slows down skin aging.

Glycerol ensures long-term preservation of the gel in the upper layers of the skin. In this combination, the product combines filling properties and biorevitalization properties simultaneously.

The product is intended for deep hydration and increasing skin elasticity and firmness.

Under the influence of sodium hyaluronate, skin cells begin to actively produce collagen on their own. The microcirculation of blood in the skin cells improves, and the skin becomes more hydrated.

The residence time of the implant in the skin layers is more than 30 days. The degree of product degradation over time depends on the condition of the patient’s skin. The implant is utilized by the surrounding tissues under the influence of a group of tissue enzymes called hyaluronidases. The degradation products are completely eliminated from the tissues by natural metabolic pathways.

Scope of Application

For increasing skin hydration and firmness by regular injection of the gel into the dermoepidermal junction area of the skin and the superficial layer of the dermis.

ICD codes

Dosage Regimen

Implant

This product should be administered by a physician who is authorized to do so under applicable local law, has received appropriate training, has relevant experience, and is well-versed in the anatomical features of the injection sites.

For intradermal injections.

Before starting the procedure, the physician must inform the patient about the indications and contraindications for the use of this product, its incompatibility with a number of other drugs, and the possible side effects/risks associated with the gel injection, and also ensure that the patient is aware of the signs and symptoms of possible complications.

The amount of substance administered depends on the areas being treated, taking into account the physician’s experience and the injection technique used. Administering too much volume of the substance can cause the development of some side effects, such as tissue necrosis and edema.

It is not recommended to repeat the procedure earlier than 15 days.

Side effects

The patient should be warned about the possibility of side reactions associated with the injection of this gel, which may develop immediately or after some time. Side effects include the following (the list provided is not exhaustive):

• After injection, there is a possibility of developing various types of skin inflammatory reactions (redness, swelling, erythema, and others), which may be accompanied by itching and/or tenderness on pressure and/or paresthesia. Such an inflammatory reaction may persist for one week;
• Occurrence of bruising;
• Transient pain or depigmentation at the injection site;
• Occurrence of indurations or nodules at the injection site;
• Staining or discoloration of tissues at the gel injection site may be observed, especially if the hyaluronic acid-based gel is injected insufficiently deeply and/or into thin skin (Tyndall effect);
• Erythema without swelling, which resolves within one week or in extreme cases persists for up to 2 months;
• Insufficient efficacy or weakly expressed effect of the procedure.

A review of products of similar composition has shown that there are reports of rare but serious adverse events associated with intravascular injection of hyaluronic acid into facial tissues and with tissue compression, namely: temporary or irreversible visual impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis and damage to underlying tissues. The injection of the gel should be stopped immediately if the patient exhibits any of the following symptoms: visual changes, signs of stroke, skin blanching, or unusual pain during or immediately after the procedure. In case of intravascular gel injection, patients should receive immediate medical attention and possibly be examined by a physician of the appropriate specialty.

There are also reports of cases of abscesses, granulomas, and immediate or delayed-type allergic reactions following hyaluronic acid injection. Therefore, it is recommended to consider the possible risk of such side effects. In this case, the physician must ensure that the patient receives appropriate treatment.

The patient must notify the physician as soon as possible of all cases of persistent local inflammatory reaction or the occurrence of any other side effects. In this case, the physician must ensure that the patient receives appropriate treatment.

Contraindications

Hypersensitivity to the components of the composition; tendency to form hypertrophic scars; history of autoimmune diseases; intake of immunomodulatory drugs; intake of anticoagulants or platelet aggregation inhibitors (e.g., acetylsalicylic acid); pregnancy, breastfeeding period; age under 18 years.

Use during pregnancy and lactation

Contraindicated for use during pregnancy and breastfeeding.

Special instructions

This product should not be administered without prior consultation with the attending physician.

The administration of this product into areas with inflammatory or infectious processes (e.g., acne, herpes, etc.) should be avoided.

Do not use concurrently with laser therapy, deep chemical peels, or dermabrasion procedures. Injection is not recommended in case of severe skin inflammation after superficial exfoliation.

Intended for intradermal injections only.

In case of increased pain sensitivity, the use of local anesthetics is possible.

Injection into the skin of the eyelids is not allowed.

Injection into blood vessels (intravascular injection) is not allowed. Intravascular injection may lead to embolization, vessel occlusion, ischemia, or infarction.

Injection into bones, tendons, ligaments, muscles, or birthmarks is excluded.

It is not recommended to inject into skin areas containing a permanent implant.

The use of decorative cosmetics should be avoided for 12 hours after the procedure.

It is necessary to avoid prolonged sun exposure, exposure to UV rays, temperatures below 0°C (32°F), visits to the sauna or steam bath for 2 weeks after the administration of this product.

There are no available clinical data concerning the tolerability of products of similar composition when used by injection in patients undergoing immunosuppressive therapy, in patients with a history of severe allergic reactions and/or polyallergic reactions.

In each specific case, the physician must decide on the possibility of using this product depending on the nature of the disease/treatment being received/existing allergy, and also ensure special monitoring of such patients. In particular, it may be suggested to perform a skin test for hypersensitivity or conduct appropriate prophylactic treatment before each gel injection, as well as to refrain from using this product in persons in the active stage of the disease.

It is not recommended to administer this product to patients with a history of anaphylactic shock. Patients with a history of streptococcal infection (recurrent tonsillitis, acute rheumatism) must undergo a skin test for hypersensitivity before each injection. In cases of acute articular rheumatism with heart involvement, it is recommended to refrain from administering this product.

Patients receiving treatment with anticoagulants or using substances that may increase bleeding duration (warfarin, acetylsalicylic acid, NSAIDs, or other substances known for their effect of increasing clotting time, for example, herbal supplements containing garlic or ginkgo biloba, etc.) should be warned about the increased risk of bleeding or bruising when this product is administered.

It is not recommended to use this product in combination with drugs that inhibit or block metabolic processes in the liver (cimetidine, beta-blockers, etc.).

Use with caution in patients with cardiac conduction disorders.

Drug Interactions

Sodium hyaluronate is incompatible with quaternary ammonium compounds (benzalkonium chloride solutions), therefore this product should not come into contact with these substances or with medical surgical instruments treated with these solutions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.