Radiesse 1x1.5ml

Sterile, pyrogen-free, latex-free, semi-solid and cohesive implant. Formulation according to the manufacturer's instructions for use:

• Mechanism: the carrier gel dissipates in vivo and is replaced by soft tissue growth, while the calcium hydroxyapatite particles remain at the injection site. CaHA is highly viscoelastic, suitable for subdermal and deep dermal placement, and provides a considerable volumising effect.
• Radiopacity: calcium hydroxyapatite is radiopaque and visible on computed tomography. The patient should report its presence before any imaging examination.
• Effect of dilution: when diluted, the product is less viscous and therefore more suitable for rejuvenation treatments of large areas, such as the décolletage.

Injectable implant intended for the augmentation of dermal and deep subdermal soft tissue in adults.

• Treatment of nasolabial folds
• Cheek augmentation
• Hand augmentation, to correct loss of volume on the dorsum
• Restoration or correction of the symptoms of facial fat loss (lipoatrophy) in people with HIV
• Moderate to severe wrinkles of the décolletage — only in a 1:2 dilution with sterile 0.9 % saline solution

Documented duration: at least 12 months in all the above indications, according to the manufacturer's clinical data.

It is not indicated for the correction of glabellar folds or the area of the nose: a higher incidence of localised necrosis has been associated with injection in these areas. The manufacturer further states that the safety and efficacy of the product in the lips have not been established, and that cases of nodules have been published following its injection into the lips.

• Injection plane: subdermal and deep dermal. Introduce the needle with the bevel facing downwards, at an angle of approximately 30° to the skin, up to the desired point.
• Technique: slow, continuous and uniform pressure on the plunger while withdrawing the needle, leaving a fine thread of material completely surrounded by soft tissue, without globular deposits. The threads are applied in parallel and may be cross-hatched in layers over a deeper plane for structural support.
• Correction factor 1:1. Do not overcorrect — the volume of the soft tissue increases over several weeks.
• Maximum annual dose: 10 ml for facial and hand indications.
• Hands: advance between the subcutaneous layer and the superficial fascia, using the skin tenting technique; boluses of 0.2–0.5 ml, not exceeding 0.5 ml per bolus or 3 ml (2 syringes of 1.5 ml) per hand. Aspirate before each bolus. Injections at the same anatomical site of the hand must be spaced at least 6 months apart.
• Décolletage — 1:2 dilution: 1.5 ml of RADIESSE® + 3.0 ml of sterile 0.9 % saline solution = 4.5 ml total volume. The mixture must be injected within 30 minutes of dilution. A sharp 27G × 3/4" needle or a blunt 25G × 50 mm cannula (TSK STERiGLIDE™) is used, with three entry points opened with a 23G needle. Linear threads of 0.1–0.25 ml are deposited retrogradely in the subdermal plane, between 18 and 45 threads, to cover a central area of about 100 cm² (equilateral triangle with sides of ~15 cm). Repeat treatment at week 16 is recommended; up to 3 treatments in 16 weeks. Maximum annual dose in the décolletage: 13.5 ml of product diluted 1:2.
• If significant resistance is felt when pushing the plunger, move the needle slightly, change position or replace the needle or the syringe.
• Massage the treated area to achieve a uniform distribution of the implant.

• Storage: inside its wrapping, at a controlled room temperature between 15 °C and 25 °C. Keep dry and away from sunlight.
• Do not use after the expiry date printed on the product labels.
• Do not use if the pack, the pouch or the syringe is damaged, or if the cap or the plunger is not intact.
• Single-use product, for one person and one treatment only. Do not re-sterilise or reuse.
• The pack contains: 1 pre-filled syringe of 1.5 ml in an aluminium pouch and a Terumo K-Pack II with 2 thin-wall 27G needles.

Contraindications: chronic and/or acute inflammation or infection in the area to be treated; severe allergies manifested by a history of anaphylaxis or the presence of multiple severe allergies; known hypersensitivity to any of the components; tendency to develop inflammatory skin conditions, hypertrophic scars or keloids; presence of foreign bodies such as liquid silicone or other particulate materials; areas without healthy, well-vascularised tissue; systemic disorders causing poor wound healing; bleeding disorders; patients under 18 years of age; pregnancy and breastfeeding.

Do not apply in the epidermis or the superficial dermis (risk of fistulas, infection, lumps, nodules and induration), or as a skin substitute. Not indicated in glabellar folds or the nasal area.

Warnings: introduction of the implant into the vascular system can cause embolisation or thrombosis, vascular occlusion, ischaemia or infarction; rare but serious cases of temporary or permanent loss of vision, blindness, cerebral ischaemia or haemorrhage resulting in stroke, and skin necrosis have been reported. Stop the injection immediately if changes in vision, signs of stroke, skin blanching or unusual pain occur. Do not inject into organs or structures that may be damaged by a space-occupying implant. Do not overcorrect. It must not be injected into people taking aspirin or other medicines that may impair wound healing. When injecting into the hands, take extreme care to avoid vessels and tendons: injection into a tendon may weaken it and cause it to rupture.

Always consult the instructions for use included in the pack before application.