RADIESSE® Plus (+) 0.8 ml - 0.8 cc with Lidocaine
- Helps correct the look of wrinkles and facial fat loss.
- Results can last up to about two years.
- Calcium hydroxylapatite provides a scaffold for new collagen growth.
- Suitable for face and hands.
Synthetic calcium hydroxylapatite; gel carrier of sterile water for injection USP, glycerin USP, and sodium carboxymethylcellulose USP; and 0.3% Lidocaine hydrochloride.
- Calcium hydroxylapatite particles: add volume and provide a scaffold for collagen growth.
- Lidocaine: an anesthetic to numb skin for greater comfort during treatment.
- Assess patient's suitability for treatment.
- Use suitable antiseptic and surgical marker to prepare patient for injection.
- Open pouch and drop syringe onto sterile field.
- Use a 25 gauge outer diameter to 27 gauge inner diameter or larger needle with standard Luer fitting. Using a needle smaller than 27 gauge inner diameter increases risk of needle blockage. Use the same needle or a different needle for different syringes used on the same patient.
- Peel or twist needle package to expose hub.
- Remove Luer syringe cap from distal end of syringe.
- Twist syringe onto needle's Luer lock fitting. Be careful not to contaminate needle.
- Tighten needle to syringe securely then push plunger to squeeze enough dermal filler out to prime needle.
- Locate injection site.
- Position needle bevel down at about a thirty degree angle to the skin. Inject into the sub-dermis at the starting location.
- Carefully push plunger and slowly inject while withdrawing needle, placing a line of filler. Continue placing lines of filler until you achieve the desired amount of augmentation. Ensure thread of material is completely surrounded by soft tissue without globular deposits.
- Use a 1:1 correction factor and do not overcorrect.
- During injection, periodically mold or massage implant to maintain a smooth contour.
- If you encounter significant resistance when pushing plunger, move needle slightly for easier placement. If you still encounter resistance, pull needle out and try a new position. If resistance still persists, try a new needle. If this still does not solve the issue, use a new syringe and needle.
- After injection, massage as needed to ensure implant is evenly distributed.
- Instruct patient in post-procedure care, including applying cool compresses to the injection area for about twenty-four hours; avoiding the sun, ultraviolet tanning lights, sauna, and intense facial treatments; massaging area gently if lumps form; and limiting talking, smiling, laughing, or other facial movements for one week.
- Also inform patient that swelling and numbness are common. Swelling usually resolves within seven to ten days but may last for several weeks. Numbness usually resolves within four to six weeks.
- Properly dispose of used syringes and needles and any unused filler left in the syringe.
- If additional treatments are needed, wait at least seven days.
- Not for use in areas with acute or chronic inflammation or infection.
- Not for use in patients with a known hypersensitivity to any ingredient in this dermal filler or to amide-type anesthetics.
- Not for use in patients who are prone to developing hypertrophic scars and keloids or patients who are prone to skin inflammation.
- Not for use in the epidermis or as a skin replacement. Superficial injections could cause fistula (hole) formation, infections, extrusions, nodule (lump) formation, and induration (hardening).
- Not for correcting glabellar folds. This could increase the risk of localized necrosis (tissue death). Injection into the glabellar or nose area could cause material to move into retinal arteries, leading to vascular occlusion (blockage).
- Not for injection into areas with liquid silicone or other particulate material.
- Only for use in areas with adequate healthy tissue coverage with good blood flow.
- Not for use in patients with systemic disorders causing poor wound healing or tissue deterioration.
- Not for use in patients with a bleeding disorder.
- Injection into blood vessels may cause embolization (blood vessel blockage), vessel occlusion (blockage), ischemia (inadequate blood supply), or infarction (blood supply obstruction causing local tissue death). Inject slowly with minimal necessary pressure. Stop injection immediately if patient has symptoms including vision changes, stroke signs, skin blanching, or unusual pain during or soon after the injection.
- Not for injection into organs or other structures that could become damaged by an implant that occupies space.
- Not for use in patients currently taking aspirin or other drugs that could inhibit healing.
- Not for injection into infected or potentially infected tissue or into open cavities, since this could cause infection or extrusion. Serious infection could cause skin damage or loss above implant. Hematomas (blood vessel buildup) or seromas (fluid buildup) may need surgical drainage.
- Hypersensitivity or allergic reaction may cause significant inflammation. Implant removal may be necessary.
- Safety during pregnancy has not been established.
- Safety during breastfeeding has not been established.
- Safety in patients under the age of 18 has not been established.
- Safety when injected into lip mucosa has not been established.
- Only for use by healthcare practitioners with training, experience, and injection site anatomy knowledge.
- Particles are visible on CT scans and may be visible in standard radiography. Patients should inform their primary doctor and radiologist of the presence of this implant. Studies suggest this implant does not mask abnormal tissue and is not misinterpreted as tumors.
- Injection carries an infection risk. Use standard injectable material precautions.
- Implant may not inject properly into scar tissue or significantly compromised tissue.
- Do not overcorrect. In extreme cases, this could cause rupture. This filler can be added but not easily removed.
- Do not resterilize. For single patient, single treatment only.
- Carefully examine pouch and syringe for damage before use. Do not use if syringe is damaged, pouch is compromised, or syringe end cap or plunger are not in place.
- It is normal for a small amount of moisture to be present inside the foil pouch for sterilization.
- Do not try to straighten a bent needle. Discard and replace needle.
- Do not recap used needles by hand.
- Clinical studies have not evaluated the safety of injections at the same time and location as epilation (hair removal), UV irradiation, radiofrequency, ablative or non-ablative laser, or mechanical or chemical peeling. Treatments after injection could cause an inflammatory reaction, as could injection before skin has healed after a treatment.
- Injection into patients with a history of herpes could reactivate the virus.
- Clinical trials have not investigated the safety of this implant beyond three years.
- If patient has congenital methemoglobinemeia with glucose-6-phosphate dehydrogenase deficiencies or who are receiving methemoglobin-inducing agent treatments, take care to determine the risk versus benefit of using this injectable.
Nodule formation requiring treatment or removal.
Implant irregularity requiring surgical correction.
Risk of infection or bleeding.
Inadequate or excessive augmentation.
Infection requiring treatment and possible implant removal.
Rarely, temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, stroke, skin necrosis (death), or damage to facial structure.
Tissue hardening at injection site, migration of particles to another part of the body, and allergic or autoimmune reactions.
During clinical trials: ecchymosis (bruising or discoloration), edema (swelling), erythema (redness), nodule (lump), pain, pruritus (itching), soreness, tenderness, numbness, contour irregularity, lumps, irritation, rash, needle jams, discoloration, hardness, headache, scab, tightness, blood-shot eyes, black eye, abrasion, spot, nerve sensitivity, dry burning sensation, warmth, stretching, pimple, flushing, fever, running ear, backed-up salivary gland, firmness, hearing loss, and puffiness.
- Injection-related reactions including bruising, erythema (redness), swelling, pain, itching, discoloration, or tenderness.
Adverse events are generally mild and of short duration. Injection-related reactions usually resolve spontaneously within a day or two after injection. If there is injection into a blood vessel, ensure patient receives prompt medical attention and possibly sees a specialist. These may not be all the possible side effects.
What is it?
Also called Radiance FN, this dermal filler gel immediately restores volume to skin, but it also contains calcium hydroxylapatite particles for long-term filling. These particles provide a scaffold for collagen growth, restoring volume to skin affected by wrinkles and age-related volume loss.
When should I use this dermal filler?
- The results of this dermal filler usually last about two years.
- Even as the filler breaks down, it leaves behind a network of new collagen growth for long-lasting results.
Why do doctors use this dermal filler?
Dermatologists, plastic surgeons, and other doctors use this dermal filler to correct facial and hand volume loss from aging or HIV. Use this dermal filler to correct nasolabial folds between the nose and mouth; marionette lines or smile lines at the corner of the mouth; radial lip lines above the upper lip; acne scars or other skin depressions and blemishes; shallow cheeks caused by fat atrophy; jaw contours; indentations, tips, bumps, and unevenness of the nose and chin; and prominent veins and bones in aged hands.
How does it work?
This dermal filler contains a gel, which immediately adds volume to the dermis but gradually dissolves. The gel carrier contains smooth, spherical calcium hydroxylapatite (CaHA) particles, which form a scaffold within the dermis. New collagen cells grow between these particles, so even as the particles themselves break down, a network of collagen is left behind. This added volume helps fill depressions and wrinkles, supporting the skin for a smooth appearance.
When and how do I use it?
How do I use this dermal filler?
Inject this dermal filler into the dermis using a needle for results that last about two years.
- This filler lasts about two years.
- Inject using a needle.
- Administer intradermally.
Can this dermal filler be combined with other treatments?
Do not inject this filler into an area containing silicone or another type of permanent implant. Ensure skin has healed after a chemical peel or similar treatment before injecting this dermal filler.
How do I store it?
Store at controlled room temperature between 15° C and 32° C (59° F and 90° F). Do not use after expiry date printed on product labels.
Where can I buy it?
You can buy it online at Doctor Medica by choosing a quantity and adding to cart. You can also phone a helpful customer service associate to order this dermal filler or other cosmetic and medical supplies.
Through Doctormedica.co, cosmetic and orthopaedic products are offered wholesale to licensed practitioners, clinics and hospitals. Go to Doctormedica.co, call 1-866-343-2413, or e-mail info@Doctormedica.co for more information.
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