Belotero Intense Lidocaine 1x1ml

Injectable filler: for medical professionals only. Belotero Intense Lidocaine is injected into the deep dermis for nasolabial folds and marionette lines, or submucosally or subcutaneously for lip enhancement. Do not inject into blood vessels: particular caution is required in the lip area. The pack contains 1 pre-filled 1 ml syringe and 2 needles 27G½".

What is Belotero Intense Lidocaine 1 ml?

Belotero Intense Lidocaine, manufactured by Anteis SA (Merz Aesthetics), is a resorbable medical device in the form of a sterile, colourless gel of cross-linked hyaluronic acid 25.5 mg/ml with lidocaine hydrochloride 3 mg/ml (0.3%). It belongs to the Belotero range of fillers manufactured with CPM (Cohesive Polydensified Matrix) technology. It is a higher-cohesivity product in this line, intended for filling deep facial folds and lines and for restoring and enhancing soft-tissue volume, including the lips. The milder Belotero Balance Lidocaine (22.5 mg/ml) is used for moderate folds and lines. See also other dermal fillers and products for lip enhancement.

Product parameters

Composition

• Cross-linked sodium hyaluronate: 25.5 mg/ml, obtained from hyaluronic acid of non-animal origin, cross-linked with BDDE using CPM technology. Degree of modification below 8%.
• Lidocaine hydrochloride: 3 mg/ml (0.3%), to reduce discomfort during injection.
• Phosphate buffer pH 7 (q.s. 1 ml): sodium chloride 8 mg/ml, sodium dihydrogen phosphate dihydrate 0.5 mg/ml and disodium phosphate 2.4 mg/ml in water for injections.
• Residual BDDE: not more than 10 ppm.

Mechanism of action

The gel, with a variable degree of cross-linking, is placed in the tissue to supplement the extracellular matrix and support the surrounding structures. The higher-density parts of the gel fill and expand the tissue, while the lower-density parts diffuse into the fine pericellular spaces, which favours even integration with the surrounding tissue. Lidocaine reduces local pain associated with the injection. The effect is temporary: hyaluronic acid is gradually resorbed.

Indications and treatment areas

Belotero Intense Lidocaine is indicated for:

• treatment of nasolabial folds (deep wrinkles) and marionette lines: injection into the deep dermis,
• lip enhancement: submucosal or subcutaneous injection.

For moderate folds and lines, Belotero Balance Lidocaine is usually selected. For work limited to the lips, in a smaller syringe volume, Belotero Lips Shape (25.5 mg/ml, 0.6 ml) is also available.

Administration: injection plane and parameters

• Injection plane: deep dermis for nasolabial folds and marionette lines; submucosal or subcutaneous for lip enhancement. The final technique and dose are chosen by the specialist.
• Needles in the pack: 2 needles 27G½".
• Dosing: the volume depends on the area and the planned correction; do not over-correct. Session limits and recommended maximum quantities per indication are given in the current instructions for use.
• The procedure is performed under aseptic conditions, into healthy, non-inflamed skin, after disinfection of the treatment area.

Duration of effect

The duration of effect is individual. In clinical data the effect lasted up to 12 months for treatment of nasolabial folds and marionette lines, and up to 3 months for lip enhancement.

Contraindications and precautions

Do not use in case of hypersensitivity to sodium hyaluronate, lidocaine, BDDE or amide-type local anaesthetics, in pregnancy or breastfeeding, in persons under 18 years of age, in general infection, in active autoimmune disease, in active cutaneous inflammation or infection at the injection site, or in an area previously treated with a permanent filler. Do not inject into blood vessels or into the glabellar or nose region.

Packaging and product data

• Pack: 1 sterile pre-filled 1 ml syringe (single use) + 2 needles 27G½".
• EAN: 7640123791275.
• Manufacturer: Anteis SA, 18 Chemin des Aulx, 1228 Plan-les-Ouates, Switzerland.

Frequently asked questions

How does Belotero Intense Lidocaine differ from the other products in the Belotero range?

The Belotero products differ in the concentration of cross-linked hyaluronic acid, the injection plane and the indications. Belotero Soft Lidocaine contains 20 mg/ml and is indicated for perioral fine lines in the superficial to mid-dermis. Belotero Balance Lidocaine contains 22.5 mg/ml: it is used for nasolabial folds, marionette lines, perioral lines and oral commissures, as well as for lip enhancement. Belotero Intense Lidocaine contains 25.5 mg/ml and is injected into the deep dermis for deep nasolabial folds and marionette lines, and submucosally or subcutaneously for lip enhancement. Belotero Lips Contour (22.5 mg/ml, 0.6 ml) is intended mainly for lip contour, perioral lines and moderate oral commissures, while Belotero Lips Shape (25.5 mg/ml, 0.6 ml) is intended for lip volume and for deep perioral lines and severe oral commissures. The choice of product is made by the specialist.

Belotero Intense or Belotero Balance: which one to choose?

Intense is chosen for deep nasolabial folds and marionette lines and when more pronounced lip enhancement is the goal. Belotero Balance Lidocaine is intended for moderate folds and lines, injected into the superficial to mid-dermis. The final choice depends on the physician's assessment.

At what depth is Belotero Intense Lidocaine injected?

For nasolabial folds and marionette lines the product is injected into the deep dermis. For lip enhancement, submucosal or subcutaneous injection is recommended.

How long does the effect last?

Duration is individual. In clinical data the effect lasted up to 12 months for nasolabial folds and marionette lines, and up to 3 months for lip enhancement.

Does Belotero Intense contain lidocaine?

Yes. The composition includes lidocaine hydrochloride 3 mg/ml (0.3%) and cross-linked sodium hyaluronate 25.5 mg/ml in a phosphate buffer.

Who may use this product?

Medical professionals only, in accordance with the current instructions for use and applicable regulations. By purchasing the product you confirm that you are authorised to perform procedures that break the continuity of tissues.

Information for specialists

The product is intended exclusively for use by appropriately trained healthcare professionals who are qualified or accredited under national law. Before treatment, take a medical history and assess the patient for contraindications, inform the patient about the nature of the procedure, possible risks and aftercare, and follow the current instructions for use.

Do not inject intravascularly. The lip area is highly vascular: particular caution and knowledge of anatomy are required. Do not inject into the glabellar or nose region. The syringe and needles are sterile and for single use; discard any leftover product and do not use if the packaging is damaged. The pack includes 2 needles 27G½".

As after any injection, transient reactions may occur at the injection site, such as swelling, redness, tenderness, a small lump or bruising, which usually resolve spontaneously within a few days.

Table of contents

• What is Belotero Intense Lidocaine 1 ml?
• Product parameters
• Composition and mechanism of action
• Indications, administration and product data
• Frequently asked questions
• Information for specialists