JUVEDERM® ULTRA 3 with Lidocaine

Manufacturing Information for Juvéderm Ultra 3

Juvéderm Ultra 3 is manufactured by Allergan from Dublin, Ireland in state-of-the-art facilities under strict quality control standards.

The Juvéderm product line also includes the following products available at Kinami Health:

• Juvéderm Volux with Lidocaine: Designed for jawline enhancement.
• Juvéderm Ultra Smile: Specifically formulated for lip augmentation.
• Juvéderm Volift with Lidocaine: Ideal for deep wrinkles and restoring facial contours.
• Juvéderm Volite with Lidocaine (Skinvive): Enhances skin hydration and elasticity.
• Juvéderm Volbella with Lidocaine: Subtle lip enhancement and fine line correction.
• Juvéderm Ultra 4: A thicker filler for deeper lines and volume loss.
• Juvéderm Volift Retouch with Lidocaine: A touch-up filler for long-lasting results.
• Juvéderm Ultra 2: Targets fine lines and superficial wrinkles.
• Juvéderm Voluma with Lidocaine: Adds volume to the cheeks and mid-face.

Expected Benefits and Results of the Treatments

Juvéderm Ultra 3 provides natural-looking facial rejuvenation with minimal downtime, offering multiple benefits for patients seeking aesthetic enhancements:

• Smooths wrinkles and folds: Reduces fine lines, nasolabial folds, and marionette lines.
• Lip augmentation: Enhances lip volume, definition, and symmetry for a youthful appearance.
• Hydrates skin: Hyaluronic acid retains moisture, improving skin texture and elasticity.
• Long-lasting results: Effects last up to a year.
• Minimal discomfort: Lidocaine ensures a more comfortable treatment experience.
• Fast recovery: Most patients resume daily activities immediately after treatment.
• Immediate visible results: Enhances facial features instantly with continued improvement over the next weeks.
• Non-surgical solution: Provides effective aesthetic results without the need for invasive procedures.
• Boosts collagen production: Encourages the skin’s natural regenerative process.
• Customisable treatment: Suitable for different areas of the face, allowing tailored results.

Juvéderm Ultra 3 Key Ingredients and Device Properties

Juvéderm Ultra 3 is formulated with high-quality ingredients and advanced technology to ensure effective, long-lasting results from dermal fillers.

Active ingredients:

• Hyaluronic acid: 24 mg.
• Lidocaine: 3 mg.
• Phosphate buffer pH 7.2 q.s: 1 ml.

Device properties:

• Cross-linked HA gel: Enhances stability and prolongs results.
• Smooth consistency: Allows for easy injection and even distribution.
• Biodegradable and resorbable: Naturally broken down by the body over time.
• Sterile and pyrogen-free: Ensures safety and reduces the risk of complications.
• Pre-filled syringes: Ready-to-use packaging for convenience and precise application.

Included Items or Accessories

Juvéderm Ultra 3 package contains the following items necessary for treatment:

• Two pre-filled syringes, 1 ml each.
• Four sterile 27G1/2” needles.
• Package insert.
• Traceability labels for patient records.

Administration Method for Juvéderm Ultra 3

Juvéderm Ultra 3 should be administered by a trained medical professional following precise injection techniques for safe and effective results.

Pre-procedure:

• Assess patient suitability.
• Disinfect treatment areas.
• Use a topical anaesthetic if required.

During procedure:

• Inject slowly into the mid to deep dermis.
• Use a linear threading or serial puncture technique.
• Avoid overcorrection to maintain natural results.

Post-procedure:

• Massage the treated area gently.
• Check for any immediate reactions.
• Provide aftercare instructions.

Guidelines for Proper Aftercare

Following the correct aftercare instructions is essential to ensure optimal results and minimise potential side effects after Juvéderm Ultra 3 treatments. Patients should:

• Avoid strenuous activity and excessive sun exposure for 24 hours.
• Do not touch or massage the area for 6-12 hours.
• Refrain from alcohol and blood-thinning medications for 48 hours.
• Use a cold compress to reduce swelling.
• Stay hydrated to support skin healing.

Potential Risks and Side Effects

While Juvéderm Ultra 3 is a safe and well-tolerated dermal filler, some patients may experience mild to moderate side effects, which typically resolve within a few days.

Common side effects:

• Redness and swelling: Temporary inflammation at the injection site.
• Mild bruising: Small bruises may appear but fade within a few days.
• Tenderness: Sensitivity in the treated area, which usually subsides quickly.
• Itching: Some patients may feel mild irritation as the skin adjusts.

Rare side effects:

• Allergic reactions: Uncommon but possible, especially in those with hypersensitivity to hyaluronic acid or lidocaine.
• Lumps or nodules: Small bumps under the skin that may require massage or correction.
• Infection: Proper sterilisation minimises this risk, but any signs of infection should be assessed by a professional.
• Vascular occlusion: A rare but serious complication that can occur if the filler is injected into a blood vessel, potentially leading to tissue damage.
• Asymmetry: Uneven results may require touch-up treatments for correction.
• Prolonged swelling or bruising: In rare cases, these effects may last longer than expected.

Juvéderm Ultra 3 Treatment Contraindications

Juvéderm Ultra 3 is not suitable for everyone. Assess patients for the following contraindications before purchase of JUVEDERM and proceeding with treatment:

• Pregnant or breastfeeding women – Not recommended due to a lack of safety data.
• Autoimmune disorders – Conditions like lupus or rheumatoid arthritis may increase the risk of adverse reactions.
• Active skin infections – Bacterial, viral, or fungal infections at the injection site must be treated before the procedure.
• Allergy to lidocaine or hyaluronic acid – Patients with known hypersensitivity should avoid this product.
• Blood clotting disorders – Conditions such as haemophilia can increase the risk of excessive bruising or bleeding.
• Recent laser or chemical peel treatments – Skin should fully heal before dermal filler application.
• History of keloid or hypertrophic scarring – Patients prone to excessive scarring may experience unwanted tissue reactions.
• Neuromuscular disorders – Conditions like myasthenia gravis or multiple sclerosis may interact with the treatment.
• Ongoing use of blood thinners – Anticoagulants like aspirin or warfarin increase the risk of bruising and complications.
• Compromised immune system – Patients undergoing chemotherapy or immunosuppressive therapy should avoid fillers.