DESCRIPTION:

O HArmonyCa is a sterile, pyrogen-free, viscous, opaque, injectable, latex-free, and biodegradable dermal implant. It consists of microspheres of synthetic calcium hydroxyapatite, formulated at a concentration of 56.7%, suspended in a non-animal origin reticulated sodium hyaluronate gel, and supplied in a pre-filled graduated glass syringe of 1.25 ml. The implant is intended for subdermal and deep dermal use in specific facial regions. The product contains 0.3% (w/v) lidocaine hydrochloride to reduce pain during treatment.

 

PACKAGE CONTENTS:

2 pre-filled syringes, each containing 1.25 ml.

2 sterile single-use 27G 1/2″ thin-wall needles.

 

COMPOSITION:

Calcium hydroxyapatite microspheres of 25-45 microns in diameter (55.7%), Reticulated sodium hyaluronate gel (20 mg/ml), Phosphate buffer. Lidocaine hydrochloride (3 mg/ml).

 

INDICATIONS:

HArmonyCa™ is a dermal filler intended for the augmentation of facial soft tissues and should be injected into the deep dermal and subdermal layers.

The lidocaine contained in the product is intended to reduce pain during treatment. Refer to the “CONTRAINDICATIONS” section for excluded facial regions.

 

CONTRAINDICATIONS:

HArmonyCa™ Lidocaine is contraindicated in the following cases:

• In patients with known sensitivity to any of the product components;
• In patients suffering from dermatitis or abnormal skin conditions;
• In patients with an infection or inflammation (acute or chronic) in or near the treatment area;
• In patients susceptible to keloid formation and/or hypertrophic scars or who develop inflammatory skin conditions;
• In patients with impaired healing due to systemic disorders, medicinal drugs, or poorly vascularized tissues;
• In patients suffering from bleeding or prolonged tissue healing due to disease or medicinal drugs;
• In patients with a clinical history of anaphylactic reactions and/or severe multiple allergies;
• In patients with known sensitivity to steroids, or who are contraindicated for steroid treatment;
• For injection in the glabellar or periocular regions;
• For injection in the lips and perioral region;
• For injection in regions containing foreign bodies;
• In patients presenting with herpes;
• In patients with autoimmune diseases;
• For injection into blood vessels and highly vascularized regions;
• For injection into the epidermis or superficial dermis;
• In breastfeeding or pregnant women;
• In patients under 18 years of age;
• In patients with known hypersensitivity to lidocaine or other amide local anesthetics;
• In patients with conditions for which lidocaine is contraindicated.

 

WARNINGS:

• HArmonyCa™ Lidocaine should not be injected into blood vessels. Aspiration before implant injection is recommended. Introduction into blood vessels can cause occlusion, ischemia, infarction, and necrosis of local or distant tissues;
• HArmonyCa™ Lidocaine should not be used in regions presenting an inflammatory reaction, infection, or tumor. Delay treatment until the reaction disappears or the disease is under control;
• The safety and efficacy of the product have not been evaluated in patients with a clinical history of keloid formation, connective tissue disorders, active bleeding disorders, active hepatitis, clinically significant abnormal laboratory results, cancer, a history of stroke/heart attack, or immunosuppressive therapy;
• The safety and efficacy of the product have not been evaluated in patients treated with other filler implants;
• The safety and efficacy of the product after dilution have not been evaluated;
• The safety of the injectable implant HArmonyCa™ Lidocaine with concomitant dermal therapies, such as depilation, ultraviolet radiation, or mechanical or chemical exfoliation procedures, has not been evaluated in controlled clinical trials;
• The safety of the product has not been evaluated in diabetic patients;
• HArmonyCa™ Lidocaine should not be used in patients undergoing treatment with substances that may prolong bleeding (e.g., aspirin, anticoagulants, thrombolytics, anti-inflammatories, angiotensin-converting enzyme inhibitors), as an increase in bruising and bleeding may occur;
• HArmonyCa™ Lidocaine should not be injected into tissues that may be damaged by the volumizing properties of dermal fillers;
• HArmonyCa™ Lidocaine should not be injected into or through scars, cartilage, and/or compromised, infected, or inflamed tissues;
• Do not overinject. Overinjection can cause mechanical tissue injuries;
• Hyaluronic acid and quaternary ammonium salts (e.g., benzalkonium chloride) are incompatible. Contact should be avoided;
• Postoperative adverse events associated with dermal fillers in general and calcium hydroxyapatite-based fillers in particular are frequently observed, some of which may require counseling and treatment by the attending physician. See the “Patient Instructions” section. Some adverse events may require surgical intervention, including hematoma or seroma drainage, as well as implant removal in cases of severe allergy, inflammation, hypersensitivity, or infection. Parte superior do formulário

 

PRECAUTIONS:

• For use only by authorized physicians in accordance with local regulations;
• For single use only and for a single patient. Do not resterilize. Only the fluid path and syringe contents are sterilized. Use as provided. Product modification may negatively affect its sterility and performance;
• For use only under sterile conditions;
• Use before the expiration date printed on the packaging;
• Do not use if the packaging is open or has been tampered with;
• Do not use in case of suspected device damage (e.g., cracked or broken syringe barrel, open syringe plunger cap or stopper). Discard any damaged devices;
• The physician should be familiar with the device and the implantation procedure and techniques. A clinical opinion regarding its application should be prepared for device use. In all cases, the user should follow safe medical practices;
• Use with caution in patients with a history of herpes or recent dental treatments or infections. Use with caution in patients currently undergoing immunosuppressive therapy;
• Use with caution when injecting in proximity to other implanted dermal fillers;
• Use with caution when injecting in marionette lines and oral commissures; do not overcorrect to prevent material migration to the lips;
• Wait at least 4 weeks between ultrasound-based treatments, laser treatments, or exfoliation and the use of this product;
• Injection of HArmonyCa™ Lidocaine may be accompanied by slight discomfort; consideration should be given to administering an anesthetic;
• As with all transcutaneous procedures, the injection of HArmonyCa™ Lidocaine carries a risk of infection. To reduce this risk, follow the common practice of such procedures.

 

STORAGE:

• Store at a temperature between 2°C and 25°C (away from light);
• Avoid prolonged exposure to high temperatures;
• Do not freeze;
• The manufacturing date can be decoded from the first 5 digits of the batch number: the first 3 digits make up the serial number (1-366) of the day (along with the year) while the 4th and 5th digits are the units digits of the year. Therefore, batch number ABCDEFG was manufactured on day number ABC in the year 20DE.

 

INSTRUCTIONS FOR USE:

• All used devices must be treated as potential biological hazards. Handle and dispose of according to standard medical practices and applicable regulations;
• Carefully inspect all parts for any damage. Do not use if any defects are suspected;
• O HArmonyCa™ Lidocaine is a homogeneous gel. Carefully inspect the gel before injection. Do not use if particles, discoloration, or signs of separation are visible;
• Patients should be instructed to refrain from using makeup in the treated area for 12 hours before and after the procedure;
• Subsequent treatments may be necessary to achieve optimal results. Allow at least seven days between treatments to effectively evaluate the treatment outcome.

 

Before Starting:

1 – Before the treatment, a complete medical history of the patient should be obtained, and the treatment area should be thoroughly assessed. Patients should be informed about the contraindications, warnings, and potential adverse events of the treatment;

2 – Assess the patient’s need to manage pain and, if necessary, apply the appropriate form of anesthesia. To reduce local swelling, ice may be applied to the injection site;

3 – Thoroughly wash the treatment area with water and soap and disinfect with an alcohol wipe. Extra attention should be given to cleaning and disinfecting the patient’s skin before the treatment to prevent bacterial infection.

 

Attaching the Needle to the Syringe:

• Sterilized disposable 27G needles are provided. It is recommended to use 25G needles or thin-wall 27G needles if needle replacement is necessary. Needle occlusion may occur more frequently when using smaller diameter needles. Larger diameter needles may result in a higher frequency of adverse events caused by skin puncture, such as pain and swelling, and should not be used. For multiple injections, it is recommended to use thin-wall 27G needles.

 

• Prepare the syringes and injection needles before the injection:

 

1. Remove the cap from the tip of the syringe by holding the syringe and unscrewing the cap.
2. Hold the body of the syringe firmly while screwing the needle hub onto the tip of the syringe.
3. Screw the needle in tight.
4. Remove any excess gel from the needle assembly surfaces using a sterilized wipe.
5. Pull the needle shield out.
6. Press the plunger rod to ensure the flow of gel out of the needle and prevent any leakage from the needle assembly surfaces. If the needle gets stuck or leakage is observed, replace the needle. In extreme cases, replace both the needle and the syringe.

 

• A new injection needle should be used for each syringe. Never transfer needles between patients.

 

Injecting the gel:

• Different facial regions and the severity of volume deficit affect the injection technique and the volume of injected implant.
• Stop the procedure immediately if there is suspicion of vascular puncture.

1 – Insert the needle into the deep dermis at an angle of -30°. The bevel should be oriented downward to minimize the implant deposit in a more superficial plane. Palpate the region with the free hand to confirm that the needle is inserted into the intended skin layer.

• Injection or superficial deposition of large volumes of implant may cause discoloration, nodules, or ischemia on the skin surface.
• Avoid injecting into or through scars and cartilaginous tissues.
• Verify (e.g., by aspiration before injection) that the implant will not be injected into a blood vessel.

2 – Inject the gel by applying gentle continuous pressure on the plunger rod while simultaneously withdrawing the needle, thereby forming a single uniform thread of gel injected into the tissue (linear threading technique). When correcting deep folds, multiple threads should be placed in layers in parallel lines under the fold. If larger volumes are needed, these layers can be deposited on top of each other, with the threads of the upper layer perpendicular to those of the lower layer (cross-hatching technique).

3 – Significant mechanical resistance to implant injection can be addressed by the following measures: Firstly, reposition the needle horizontally; secondly, inject from a different entry point; thirdly, replace the needle or even the syringe.

4 – Blanching may indicate injection into a superficial skin layer or a blood vessel. In case of blanching, stop the injection and massage the area until the color returns to normal. If the skin color does not return to normal, the injection process should not be resumed, and vasodilatory measures or others should be considered.

5 – Stop the injection before pulling the needle out of the skin to prevent gel leakage into superficial skin layers.

6 – Avoid overcorrection.

7 – Dispose of the needle in an appropriate biohazard waste container.

8 – Repeat the procedure if any additional correction is necessary, but only after meticulous evaluation of the treated area and the patient’s condition.

9 – After completing the injection, gently massage the treated area to ensure even distribution of the gel and shape it to the contour of the tissues.

10 – In case of overcorrection, massage the area firmly to achieve optimal results.

 

Patient Instructions:

The following information should be shared with the patient:

1 – The patient should avoid vigorous activity and exposure to sunlight and tanning lamps or extreme weather conditions for 24 hours after the treatment to reduce redness, swelling, and irritation.

2 – The patient should apply ice or cold compresses to the treated area for 24 hours after the treatment to reduce redness, swelling, and irritation.

3 – If nodules appear, the patient should massage the treated area.

4 – The patient should be informed that the injected material may be palpable for an extended period of time after the treatment.

5 – Common post-operative adverse events include erythema, edema (swelling), pain, tenderness, and itching. Reactions in the treatment area typically disappear within 24-48 hours, and swelling within a week.

6 – Less common adverse events associated with dermal fillers in general, and calcium hydroxyapatite-based fillers in particular, include hematoma, seroma, extrusion, hardening, skin pigmentation, fistula formation, inflammatory reaction, infection, allergic reaction, migration, persistent nodules, granulomas, necrosis, and blindness.