JUVÉDERM® ULTRA 4

Manufacturing Information for Juvéderm Ultra 4

Allergan, located in Dublin, Ireland, manufactures Juvéderm Ultra 4 respecting stringent standards and regulations across its facilities.

Other products in the Juvederm range include:

• Juvéderm Volift Retouch with Lidocaine: Ideal for minor touch-ups and refinements.
• Juvéderm Volbella with Lidocaine: Specifically formulated for delicate lip enhancement and perioral lines.
• Juvéderm Ultra 2: Used for treating moderate facial wrinkles and subtle lip definition.
• Juvéderm Volux with Lidocaine: Designed for jawline and chin augmentation.
• Juvéderm Ultra 3: Suitable for deep wrinkles and fuller lip enhancement.
• Juvéderm Volite with Lidocaine (Skinvive): A skin booster that improves hydration and elasticity.
• Juvéderm Ultra Smile: Tailored for lip contouring and volume increase.
• Juvéderm Voluma with Lidocaine: Provides long-lasting cheek volume restoration.
• Juvéderm Volift with Lidocaine: Offers mid-face volume enhancement with natural results.

Expected Benefits and Results of the Treatments

Juvéderm Ultra 4 provides effective, long-lasting results, including:

• Immediate improvement: Visible enhancement right after the procedure.
• Long-lasting results: The results can last for months without touch-ups.
• Deep wrinkle reduction: Smooths severe nasolabial folds, marionette lines, and other deep facial wrinkles.
• Enhanced facial volume: Restores lost volume in the cheeks, jawline, and chin for a youthful appearance.
• Natural-looking outcomes: The smooth gel consistency integrates seamlessly with facial tissues.
• Hydrating effect: Hyaluronic acid retains moisture, improving skin elasticity and hydration.
• Minimally invasive procedure: Provides significant results without the need for surgery or extended downtime.

Juvéderm Ultra 4 Key Ingredients and Device Properties

Juvéderm Ultra 4 has the following device properties and active ingredients:

Active ingredients

• 1 ml of phosphate buffer pH 7.2 q.s.

• 24 mg/ml of hyaluronic acid.
• 3 mg/ml of lidocaine.

Device properties:

• HYLACROSS™ technology: Ensures a smooth, malleable gel for precise application and long-lasting results.
• Cross-linked HA gel: Enhances stability and durability for extended effectiveness.
• Smooth consistency: Allows for even distribution and seamless integration with facial tissues.

Included Items or Accessories

Juvéderm Ultra 4 box includes the following:

• 2 x 1ml pre-filled syringes.
• 4 sterile 27G needles.
• Product leaflet.
• Traceability labels.

Administration Method for Juvéderm Ultra 4

Proper administration of Juvéderm Ultra 4 is essential to achieve optimal results, ensuring precise placement and patient safety during the procedure.

Pre-procedure:

• Assess patient’s medical history.
• Cleanse and disinfect the injection area.
• Apply numbing cream if necessary.

During procedure:

• Use a 27G needle for injection.
• Inject slowly into the deep dermis or subcutaneous layer.
• Massage the area gently to ensure even distribution.

Post-procedure:

• Apply a cold compress to reduce swelling.
• Monitor for side effects and reactions.

Guidelines for Proper Aftercare

Following the correct aftercare instructions helps maintain optimal results, minimise side effects, and promote a smooth recovery after Juvéderm Ultra 4 treatments. Recommend to patients to do the following:

• Avoid excessive facial movement for 24 hours.
• Refrain from touching or massaging the area.
• Avoid alcohol and blood-thinning medications for 48 hours.
• Stay away from saunas, steam rooms, and direct sunlight for a week.
• Keep the area clean and moisturised.

Potential Risks and Side Effects

While Juvéderm Ultra 4 is generally safe and well-tolerated, some patients may experience temporary side effects, and in rare cases, more serious complications may occur.

Common side effects:

• Itching or irritation: Mild irritation as the skin adjusts to the filler.
• Tenderness or sensitivity: Temporary discomfort in the treated area.
• Redness and swelling: Mild inflammation at the injection site, usually resolving within a few days.
• Lumps or uneven texture: Small nodules may form but usually smooth out with a gentle massage.
• Bruising: Small bruises may develop but fade naturally over time.

Rare side effects:

• Skin discolouration: Temporary or permanent pigment changes in the treated area.
• Vascular occlusion: Accidental injection into a blood vessel can cause tissue damage or, in severe cases, necrosis.
• Delayed-onset nodules: In rare cases, firm lumps may appear weeks or months after treatment and require medical intervention.
• Allergic reactions: Hypersensitivity to hyaluronic acid or lidocaine, though uncommon.
• Asymmetry or uneven results: Uneven distribution of filler may require touch-up treatments.
• Infection: Improper aftercare or unsterile conditions may lead to infection at the injection site.
• Prolonged swelling or bruising: Some patients may experience persistent swelling or discolouration.

Juvéderm Ultra 4 Treatment Contraindications

Juvéderm Ultra 4 is not suitable for all patients, and the following medical conditions or factors may increase the risk of complications, making treatment unsafe or less effective:

• Allergy to lidocaine or hyaluronic acid: Contraindicated for individuals with known hypersensitivity.
• Severe allergies or anaphylaxis history: Individuals prone to severe allergic reactions should avoid dermal fillers.
• Blood clotting disorders: Patients with haemophilia or those taking anticoagulants have a higher risk of excessive bruising or bleeding.
• Autoimmune disorders: Patients with conditions like lupus or rheumatoid arthritis should consult a specialist.
• Keloid or hypertrophic scarring tendency: Patients with a history of excessive scarring may not be ideal candidates.
• Active skin infections: Increases the risk of complications at the injection site.
• Recent laser treatments or chemical peels: Skin sensitivity may be heightened, increasing the risk of irritation.
• Neurological disorders: Conditions like myasthenia gravis or Bell’s palsy may interact negatively with dermal fillers.
• Pregnant or breastfeeding women: Not recommended due to a lack of safety data.
• Under 18 years of age: Not approved for use in minors.
• Uncontrolled diabetes: Poor wound healing may increase the risk of complications.
• History of skin disorders: Patients with eczema, psoriasis, or rosacea in the treatment area may experience flare-ups.
• Compromised immune system: Patients undergoing chemotherapy or immunosuppressive treatments may be at a higher risk of infection.
• Unrealistic expectations: Patients seeking extreme or unnatural results may not be suitable candidates for treatment.
• Severe cardiovascular conditions: Those with heart disease should consult a doctor before undergoing filler injections.