Radiesse With Lidocaine Sir 1.5Ml

Radiesse® (+) Lidocaine 1.5cc

Description:

Injectable implant Radiesse® (+) Lidocaine (hereinafter referred to as injectable Radiesse® (+) implant) is an opaque, sterile, non-pyrogenic, semi-solid, cohesive implant, whose main component is synthetic calcium hydroxyapatite suspended in a glycerin gel carrier, sodium carboxymethylcellulose, lidocaine hydrochloride at 0.3% and sterile water for injectable preparations. RADIESSE® (+) injectable implant (1.5 cc and 0.8 cc) has a particle size range of calcium hydroxyapatite of 25–45 microns and must be injected with a needle with an outer diameter (outer diameter) of 25 gauge to an inner diameter (inner diameter) of 27 gauge (inner diameter).

Intended Use and Indications:

Radiesse® (+) Lidocaine 1.5cc is an injectable implant indicated for subdermal implantation for the correction of moderate to severe wrinkles and folds of the face, such as nasolabial folds.

Contraindications:

• Radiesse® (+) Lidocaine 1.5cc is contraindicated for patients with severe allergies manifested by a history of
anaphylaxis or a history or presence of multiple severe allergies.
• Radiesse® (+) Lidocaine 1.5cc should not be used in patients with known hypersensitivity to any of the components.
• The injectable implant Radiesse® (+) Lidocaine 1.5cc is not intended for use in patients with known hypersensitivity
to lidocaine or amide-type anesthetics.
• The injectable implant Radiesse® (+) Lidocaine 1.5cc is contraindicated for patients with bleeding disorders.

Warnings:

• The introduction of Radiesse® (+) Lidocaine 1.5cc into the vascular system may lead to embolization, vessel occlusion, ischemia, or infarction. Specific attention should be paid during injection, for example, soft tissue fillers should inject Radiesse® (+) Lidocaine 1.5cc slowly and apply the minimal amount of pressure necessary. Rare but serious adverse events associated with intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.
Immediately discontinue the injection if a patient demonstrates any of the following symptoms, including changes in vision, signs of stroke, skin blanching, or unusual pain during or shortly after the procedure. Patients should receive timely medical attention and possibly evaluation by an appropriate healthcare specialist in case of intravascular injection.
• Use of the injectable Radiesse® (+) Lidocaine 1.5cc in implant in any person with active skin inflammation or infection within or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
• Do not excessively correct (overfill) a contour deficiency as the depression should gradually improve within weeks of the therapeutic effect of the injectable implant Radiesse® (+) Lidocaine 1.5cc .
• The safety and efficacy for use in the lips have not been established. There have been published reports of nodules associated with the use of the injectable implant Radiesse® (+) Lidocaine 1.5cc injected into the lips.
• Reactions to the injection procedure have primarily consisted of short-term (i.e., <7 days) bruising, redness, and swelling. Refer to the Adverse Events section for details.

Precautions:

• To minimize the risks of potential complications, Radiesse® (+) Lidocaine 1.5cc should only be used by healthcare professionals who have adequate training, experience, and knowledge of the anatomy at and around the injection site.
• In order to minimize the risks of potential complications, healthcare professionals should fully familiarize themselves with the product, the product educational materials, and the entire package insert.
• The calcium hydroxyapatite (CaHA) particles of the injectable Radiesse® (+) Lidocaine 1.5cc implant are radiopaque and are clearly visible on CT scans and may be visible in standard X-rays. Patients should be informed of the radiopaque nature of the injectable Radiesse® (+) Lidocaine 1.5cc implant so that they can inform their healthcare providers and radiologists. In a radiographic study of 58 patients, there was no indication that the injectable Radiesse® (+) Lidocaine 1.5cc masked abnormal tissues or was misinterpreted as tumors on CT scans.
• Healthcare providers are encouraged to discuss all potential risks of soft tissue injections with their patients before treatment and ensure that patients are aware of signs and symptoms of potential complications.
• As with all transcutaneous procedures, the injection of the injectable Radiesse® (+) Lidocaine 1.5cc implant carries a risk of infection. Infection may require an attempt at surgical removal of Radiesse® (+) Lidocaine 1.5cc. Standard precautions associated with injectable materials should be followed.
• Patients who are taking medications that may prolong bleeding, such as aspirin or warfarin, may, as with any injection, experience increased bruising or bleeding at the injection site.
• In cases of laser treatment, chemical peels, or any other procedure based on the active skin response considered after treatment with the injectable RADIESSE® (+) implant, there is a possible risk of inducing an inflammatory reaction at the implant site. This also applies if it is an injectable RADIESSE® (+)
administered before the skin is completely healed following such a procedure.
• The long-term safety of the injectable RADIESSE® (+) implant has not been studied in clinical trials.
• Safety of the injectable Radiesse® (+) Lidocaine 1.5cc for use during pregnancy, in breastfeeding women, or in patients under 18 years of age has not been established.
• Safety of the injectable Radiesse® (+) Lidocaine 1.5cc in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied.
• Safety of the injectable Radiesse® (+) Lidocaine 1.5cc with concomitant skin therapies such as hair removal procedures, UV irradiation, or mechanical or chemical peels has not been assessed in controlled clinical studies.
• Injection of the injectable Radiesse® (+) Lidocaine 1.5cc in patients with a history of previous herpes outbreak may be associated with the reactivation of herpes.
• No study of interactions of the injectable Radiesse® (+) Lidocaine 1.5cc with medications or other substances has been conducted.
• Safety and efficacy in the periorbital area have not been established.
• The patient should be informed that they should minimize exposure of the treated area to excessive sun or heat for about 24 hours after treatment or until any initial swelling and redness have resolved.
• Universal precautions must be observed in case of potential contact with the patient's body fluids. The injection session must be conducted with aseptic technique.
• The injectable Radiesse® (+) Lidocaine 1.5cc is packaged for single patient use. Do not re-sterilize. Do not use if the package is opened or damaged. Do not use if the syringe's end cap or the syringe plunger is not in place.
• To avoid breaking the needle, do not attempt to straighten a bent needle. Discard and complete the procedure with a replacement needle.
• Do not recap used needles. Hand recapping is an unsafe practice and should be avoided. 3
• After use, syringes and needles for treatment may be potential biological hazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state, and federal requirements. • Exercise caution in assessing the risk versus benefit for patients with congenital methemoglobinemia, glucose-6-phosphate dehydrogenase deficiency, and in patients receiving concomitant treatment with methemoglobin-inducing agents.

* The application of the product is reserved exclusively for healthcare professionals with appropriate qualifications.

MEDICAL DEVICE