Belotero Radiesse+ 1.5ml
Merz
Injectable dermal fillerCalcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Certifications
- CE Marked calcium hydroxylapatite injectable implant for aesthetic and plastic/reconstructive indications in applicable markets.
- FDA Approved as Radiesse (+) with lidocaine for correction of moderate to severe facial wrinkles and folds (e.g., nasolabial folds) and improvement of moderate to severe loss of jawline contour in adults over 21, where authorised.
- Class III medical device status under EU medical device regulations for injectable implants (CaHA CMC based dermal filler).
- Manufactured under Good Manufacturing Practice (GMP) and applicable quality system regulations for medical devices.
- Complies with Merz Aesthetics internal quality, safety, and pharmacovigilance standards for injectable aesthetic products.
- CE Marked calcium hydroxylapatite injectable implant for aesthetic and plastic/reconstructive indications in applicable markets.
- FDA Approved as Radiesse (+) with lidocaine for correction of moderate to severe facial wrinkles and folds (e.g., nasolabial folds) and improvement of moderate to severe loss of jawline contour in adults over 21, where authorised.
- Class III medical device status under EU medical device regulations for injectable implants (CaHA CMC based dermal filler).
- Manufactured under Good Manufacturing Practice (GMP) and applicable quality system regulations for medical devices.
- Complies with Merz Aesthetics internal quality, safety, and pharmacovigilance standards for injectable aesthetic products.
Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Description
Belotero Radiesse+ 1.5ml is a professional-use, calcium hydroxylapatite (CaHA) based, biostimulatory dermal filler with integrated 0.3% lidocaine. Supplied by Fillers Direct under the Merz (MERZ) filler category, it is designed for deep dermal and sub-dermal soft tissue augmentation to correct moderate to severe facial wrinkles and folds, restore volume, and improve jawline contour. The CaHA microspheres are suspended in a sterile carboxymethylcellulose (CMC) gel carrier with glycerin and water, providing immediate lifting and volumizing effects while stimulating the body’s own collagen and elastin production for long-lasting improvement in skin quality. The lidocaine content enhances patient comfort during injection. This 1.5 ml prefilled syringe configuration is intended for use by trained healthcare professionals only.
Bnefits
- Immediate volumizing and lifting effect with visible correction at the time of injection
- Biostimulatory action – CaHA microspheres stimulate neocollagenesis and neoelastinogenesis for long-term skin quality improvement
- Long-lasting results, typically around 12–18 months depending on treatment area, technique, and patient factors
- Integrated 0.3% lidocaine to reduce injection-related discomfort
- Provides structural support and contouring, especially suited to areas requiring lift and definition
- Non–hyaluronic acid filler, useful where a firmer, more supportive product is desired
- CE-marked CaHA injectable implant widely used in aesthetic and plastic/reconstructive indications
- Single-use, prefilled sterile syringe presentation with matched needles for controlled administration by professionals
Indications
- Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (nose-to-mouth lines)
- Deep injection (subdermal and/or supraperiosteal) to improve moderate to severe loss of jawline contour in adults over 21 years of age
- Augmentation of cheeks and midface to correct volume loss and improve facial contour (off-label uses depend on local regulations)
- Treatment of marionette lines and chin folds as part of lower-face rejuvenation protocols
- Deep dermal and sub-dermal soft tissue augmentation of the facial area in plastic and reconstructive/aesthetic procedures
- Hand augmentation to correct volume loss in the dorsum of the hands (where Radiesse/Radiesse+ is approved/labelled for this use; practitioners must follow local indications)
Composition
- Synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% w/v), particle size range typically 25–45 µm
- Aqueous gel carrier (approximately 70% w/v) composed of sterile water for injection, glycerin and sodium carboxymethylcellulose (NaCMC)
- Lidocaine hydrochloride 0.3% (integrated local anaesthetic)
- Physiological excipients as per official Radiesse (+) Lidocaine instructions for use
- Sterile, non-pyrogenic, latex-free, bioresorbable implant
Formulation
- Sterile, non-pyrogenic, semi-solid, cohesive injectable implant
- Biocompatible CaHA microspheres suspended in a carboxymethylcellulose gel matrix
- Pre-filled, single-use 1.5 ml syringe for subdermal and deep dermal implantation
- Contains integrated 0.3% lidocaine for enhanced patient comfort
- Intended exclusively for administration by trained healthcare professionals experienced in injectable aesthetic procedures
Packaging
- 1 x 1.5 ml prefilled syringe of Radiesse+ Lidocaine (CaHA injectable implant)
- Typically supplied with 1 or 2 sterile needles (25–27G, lengths as per manufacturer’s IFU – commonly 25G or 27G 3/4")
- Sterile blister packaging within a cardboard carton
- Package insert / instructions for use (IFU) and patient implant card (where applicable)
- External carton labelled with batch number, expiry date, and storage conditions
Usage
- For professional use only – inject only by suitably trained and qualified healthcare professionals familiar with facial anatomy and CaHA fillers.
- Indicated for subdermal and/or supraperiosteal injection, typically using a 25–27G needle as specified in the official Radiesse (+) Lidocaine Instructions for Use.
- Use strict aseptic technique; disinfect the treatment area thoroughly before injection.
- Inject slowly with minimal pressure and avoid overcorrection; product provides immediate volume plus progressive collagen stimulation.
- After injection, gently massage the treated area to ensure even distribution and contouring, according to the IFU and practitioner’s training.
- Do not inject into blood vessels. Avoid high-risk vascular areas and always aspirate in accordance with current best practice and training.
- Do not use in areas with active skin infection or inflammation (e.g., acne, dermatitis, herpes infection) at the intended injection site.
- Single-patient, single-use device – do not resterilize or reuse. Discard any unused product following injection in accordance with local regulations.
- For detailed dosing, anatomical guidance, contraindications, warnings, and technique recommendations, consult the current official Radiesse (+) Lidocaine Instructions for Use and follow local regulatory labelling.
Contraindications
- Known hypersensitivity or allergy to any of the components of the product (e.g., calcium hydroxylapatite, lidocaine, glycerin, sodium carboxymethylcellulose).
- Known hypersensitivity to lidocaine or other local anaesthetics of the amide type.
- Patients with severe allergies manifested by a history of anaphylaxis or a history/presence of multiple severe allergies.
- Patients with bleeding disorders or significant coagulation abnormalities.
- Presence of active infection, inflammation, or skin disease at or near the intended injection site.
- Patients who are prone to abnormal scarring (e.g., hypertrophic scars or keloids) or have active inflammatory skin conditions in the treatment area.
- Intravascular injection is strictly contraindicated; do not inject into blood vessels.
- Use in pregnancy or breastfeeding is generally not recommended due to lack of adequate safety data (practitioners must follow local labelling and clinical judgement).
Adverse Effects
- Common, typically transient injection-site reactions such as pain, tenderness, erythema (redness), swelling, oedema, bruising, and itching.
- Nodules, lumps or bumps, induration, or palpable product at or near the injection site.
- Asymmetry, contour irregularities, or over- or under-correction of treated areas.
- Injection-site discoloration, ecchymosis, or haematoma.
- Hypersensitivity reactions including local inflammatory responses (redness, swelling, warmth) and, rarely, more extensive allergic reactions.
- Infection at the injection site, including granuloma formation or abscess formation in rare cases.
- Very rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, tissue ischemia or necrosis, and visual disturbances or blindness if product is embolised into critical vessels.
- Other adverse events described in the official Radiesse (+) Lidocaine safety information and Instructions for Use; practitioners must familiarise themselves fully with these before treatment.
Storage Conditions
- Store in accordance with the manufacturer’s labelling – typically at controlled room temperature (e.g., 2–25 °C or within the range stated on the carton).
- Do not freeze the product. Protect from excessive heat and direct sunlight.
- Keep the syringe in its original packaging until use to maintain sterility and protect from light.
- Do not use after the expiry date printed on the outer carton and syringe label.
- Single-use medical device – once opened and used for a single patient, any remaining product must be discarded.
Duration
Typically around 12\u201318 months, with some patients and indications (e.g., jawline contour, hand augmentation) experiencing sustained effects beyond 18 months depending on injection technique, treatment area, metabolism, and lifestyle factors.
Onset
Immediate visible lifting and volumizing effect at the time of injection, followed by progressive improvement over several months as new collagen and elastin are deposited around the CaHA microspheres.
