RADIESSE® INJECTABLE PLANT 1.5ml

RADIESSE® Injectable Implant is a sterile implant:
- Latex-free, apyrogenic, semi-solid and cohesive.
- A whitish, viscoelastic implant consisting of a homogeneous suspension of calcium hydroxyapatite (CaHA) microspheres in an aqueous carboxymethylcellulose gel.
- Composed of 56% CaHA particles 25-45 µm (w/w), 44% gel (w/w) - 36.0% sterile water for injection - 6.6% glycerine - 1.4% sodium carboxymethyl cellulose (NaCMC).
- Treatment of nasolabial folds, cheek augmentation procedure, hand volume restoration procedure to correct volume loss in the back of the hands, restoration and/or correction of signs of facial adipose tissue loss (lipoatrophy) in human immunodeficiency virus-infected subjects, treatment of moderate to severe décolleté wrinkles.
- Biphasic technology based on calcium hydroxyapatite (CaHA) microspheres.
- Its formulation is based on synthetic calcium hydroxyapatite (CaHA) microspheres suspended in an aqueous carrier gel, to which a percentage of lidocaine is added for injection comfort.

- MERZ PHARMA ITALIA S.P.A.
- NAME: RADIESSE® INJECTABLE IMPLANT
- COMPOSITION: 56% CaHA particles 25-45 µm (w/w), 44% gel (w/w) - 36.0% sterile water for injections - 6.6% glycerine - 1.4% sodium carboxymethylcellulose (NaCMC).
- PRESENTATION: 1 x 1.5ml.
- NEEDLES: 2 x 27G thin-walled injection needles.
- INDICATIONS: RADIESSE® Injectable Implant is indicated for deep dermal and subdermal soft tissue augmentation.
- INJECTION DEPTH: Percutaneous.
- DURATION: 1 year.
- USE: Strict medical use.

- Syringe: 1 x 1.5 ml.
- Needles: 2x 27G thin-walled injection needles.
- One syringe contains 1.5 mL of RADIESSE® Implant Injectable.
- The gel is sold in a pre-filled, steam-sterilised disposable syringe.
- Each box contains one 1.5mL syringe of RADIESSE® Implant Injectable, 2 sterile single-use 27G thin-walled injection needles reserved exclusively for RADIESSE® Implant Injectable, instructions for use and labels to ensure traceability.

Face and hands.

COMPOSITION RADIESSE® Injectable Implant
- 56% CaHA particles 25-45 µm (w/w)
- 44% gel (w/w)
- 36.0% sterile water for injections
- 6.6% glycerine
- 1,4% sodium carboxymethyl cellulose (NaCMC)

- In order to minimise the risk of potential complications, RADIESSE® Implant Injectable should only be used by healthcare professionals with appropriate training and experience and who are familiar with the anatomy of the injection site and surrounding areas.
- In order to minimise the risk of potential complications, healthcare professionals should study the product, the instructional material and the entire package leaflet.
- Healthcare professionals are encouraged to discuss the potential risks of soft tissue injection with their patients prior to treatment and to ensure that patients are aware of the signs and symptoms of potential complications.
- As with all transcutaneous procedures, injection of the RADIESSE® Injectable Implant carries the risk of infection. Infection may require surgical removal of the RADIESSE® Injectable Implant. Use standard precautions for injectable materials.
- Patients using drugs that prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site, as would occur with any injection.
- The chalconium hydroxyapatite (CaHA) particles in RADIESSE® Injectable Implant are radio-opaque and clearly visible in CT scans, MRI scans, mammograms or even plain radiographs. People should be made aware of the radio-opaque nature of RADIESSE® Implant Injectable so that they can communicate this to their general practitioner and radiologist. An X-ray study of 58 people found no cases where RADIESSE® Implant Injectable masked the presence of abnormal tissue or was detected as a tumour mass on CT scans.
- To facilitate percutaneous injection, apply RADIESSE® Injectable Implant into soft tissue. Scarred or severely compromised tissue may not tolerate the treatment.
- Infections may occur at the injection site and must be treated appropriately. If such infections cannot be eradicated, the implant may have to be removed.
- Injection-associated reactions such as erythema, swelling, pain, itching, discolouration or sensitivity may occur at the injection site. These phenomena generally disappear spontaneously one or two days after injection.
- Nodules may form that require medical treatment or removal.
- Any irregularities in the contour may require corrective surgery.
- Do not inject an overdose into the area to be treated. In extreme cases, rupture of the injection site may occur. RADIESSE® Implant Injectable can be added easily in subsequent injections, but cannot be removed as easily.
- The RADIESSE® Implant Injectable procedure presents slight risks of infection and/or bleeding, similar to other injection procedures. The patient may experience mild discomfort during and after the procedure. Therefore, consider using common anaesthetic techniques for this treatment. To prevent possible infection, follow the normal precautions for percutaneous injection procedures.
- Do not re-sterilise. RADIESSE® Implant Injectable is supplied sterile and non-pyrogenic in a sealed film pouch and is intended for single patient use and treatment.
- Carefully examine the aluminium pouch to check that neither the pouch nor the syringe has been damaged during shipment. Do not use the product if there is a compromised pouch or damaged syringe. Do not use the syringe if the protective cap or plunger is not in place. Normally, a small amount of moisture from sterilisation forms inside the aluminium pouch: this does not indicate a defective product.
- To avoid needle breakage, do not attempt to straighten bent needles. Discard them and complete the procedure with the replacement needle.
- Do not cap used needles. Replacing the needle cap by hand is a dangerous procedure that should not be performed.
- The safety of RADIESSE® Implant Injectable with concomitant dermal therapies, such as hair removal, UV radiation, radiofrequency, ablative (and non-ablative) laser treatments, and chemical or mechanical peeling, has not been evaluated in experimental clinical studies.
- No studies have been conducted on the interactions of RADIESSE® Injectable Implant with different drugs, substances or implants.
- Limited clinical data are available on the combination of RADIESSE® Implant Injectable with BELOTERO® products and/or botulinum toxin. As a precaution, inject the products into different areas of the face. Healthcare professionals must be experienced and appropriately selected, as not only the benefits but also the side effects/adverse events may accumulate, making it difficult to determine the causation of side effects/adverse events. Observe the instructions for use, injection depth and appropriate indication of each product.
- Observe universal precautions when there is a risk of contact with a patient's body fluids. Conduct the treatment session with aseptic technique.
- If a laser treatment, chemical peel or any other procedure based on an active dermal response is considered after treatment with RADIESSE® Implant Injectable, there is a risk of provoking an inflammatory reaction at the implant site. This risk also exists if RADIESSE® Implant Injectable is administered prior to complete healing of the skin after such a procedure.
- RADIESSE® Implant Injectable in patients with a history of a previous herpetic rash may be associated with reactivation of the herpes virus.

- RADIESSE® Implant Injectable is contraindicated in the presence of acute and/or chronic inflammation or infection involving the area to be treated.
- RADIESSE® Implant Injectable is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, as well as in the case of a history or presence of several severe allergies.
- Do not use RADIESSE® Implant Injectable in patients with known hypersensitivity to any of the components of the product.
- RADIESSE® Injectable Implant is contraindicated in individuals prone to developing inflammatory skin conditions or with a tendency to develop hypertrophic and keloid scars.
- Do not implant the product into the epidermis or use it as a skin substitute. Implantation in the epidermis or superficial dermis may cause complications such as fistula formation, infection, extrusion, nodules and induration.
- RADIESSE® Injectable Implant is not indicated for the correction of glabellar and nasal area wrinkles. Injections into the glabellar and nasal area are associated with an increased incidence of localised necrosis. A forced injection into the vessels of the superficial dermis of the glabellar or nasal area may cause retrograde movement of the retinal arteries and lead to vessel occlusion.
- RADIESSE® Injectable Implant is contraindicated in the presence of foreign bodies such as liquid silicone or other particulate materials.
- Do not use RADIESSE® Implant Injectable in areas where there is inadequate coverage of healthy, well-vascularised tissue.
- Do not use RADIESSE® Implant Injectable on patients with systemic disorders that slow or complicate wound healing or are capable of causing tissue deterioration over the implant.
- RADIESSE® Injectable Implant is contraindicated in individuals with bleeding disorders.
- RADIESSE® Implant Injectable is contraindicated in persons under the age of 18.
- RADIESSE® Injectable Implant is contraindicated in women during pregnancy and lactation.

RADIESSE® + Lidocaine Injectable Implant is indicated for:
- The treatment of nasolabial folds.
- Cheek augmentation.
- Hand volume restoration procedure to correct volume loss in the back of the hands.
- Restoration and/or correction of signs of facial adipose tissue loss (lipoatrophy) in subjects with human immunodeficiency virus.
- Treatment of moderate and severe wrinkles of the décolleté.

The contents of the RADIESSE® Injectable Implant syringe are steam sterilised. The 27G needles are sterilised with ethylene oxide.