Azzalure 125 IU

Azzalure® 125 Speywood Units is a prescription injectable medication containing botulinum toxin type A (Clostridium botulinum toxin type A haemagglutinin complex). It is specifically developed for aesthetic use and is indicated for the temporary improvement of certain dynamic facial wrinkles caused by repeated muscle contractions. Azzalure is marketed by Galderma and is the aesthetic formulation of Dysport® in many European markets. The active ingredient is: Azzalure Azzalure 125 Speywood Units is supplied as a sterile, lyophilized (freeze-dried) powder in a single-use vial. Before administration, it is reconstituted with sterile sodium chloride solution for injection and administered intramuscularly by qualified healthcare professionals. The Speywood Units used for Azzalure are specific to this product and must not be compared or exchanged with the units of other botulinum toxin products.

Composition

Each vial contains:

• 125 Speywood Units of botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex)
• Human albumin
• Lactose monohydrate

The formulation is preservative-free and intended for single-patient use after reconstitution.

Storage Requirements

To maintain product quality:

• Store refrigerated at 2°C–8°C.
• Do not freeze.
• Protect from excessive heat and light.
• Reconstitute only with sterile saline.
• Use the reconstituted solution within the manufacturer’s recommended timeframe using aseptic technique.

Safety Information

Azzalure is a prescription medicine and should only be administered by qualified healthcare professionals.

Treatment may not be suitable for individuals with:

• Hypersensitivity to botulinum toxin type A or any ingredient in the formulation
• Infection at the intended injection site
• Certain neuromuscular disorders

Possible side effects include:

• Injection-site pain or bruising
• Headache
• Temporary eyelid drooping
• Localized muscle weakness
• Swelling or redness at the injection site

Although uncommon, serious adverse reactions such as difficulty swallowing, speaking, or breathing require immediate medical attention.

Mechanism of Action

Azzalure temporarily blocks the release of acetylcholine at the neuromuscular junction, preventing muscle contraction in the treated area.

This results in:

• Temporary relaxation of targeted facial muscles
• Softening of dynamic facial wrinkles
• Smoother skin appearance while preserving natural facial expression when administered appropriately

Product Features

• 125 Speywood Units per vial
• Botulinum toxin type A formulation
• Sterile lyophilized powder
• Single-use vial
• Designed specifically for aesthetic treatments
• Administered only by qualified healthcare professionals
• Product-specific potency units

1. Minimally Invasive

Provides wrinkle reduction without surgery.

2. Fast Onset

Visible improvements often begin within a few days.

3. Clinically Established

Botulinum toxin type A has extensive clinical use in aesthetic medicine.

4. Temporary Results

Effects gradually diminish, allowing individualized treatment schedules.

5. Designed for Aesthetic Use

Specifically developed for cosmetic facial wrinkle treatment in approved markets.

Approved Cosmetic Uses

Depending on local regulatory approvals, Azzalure is indicated for the temporary improvement of:

• Glabellar (frown) lines between the eyebrows
• Lateral canthal lines (crow’s feet)

These treatments are intended for adult patients when the severity of the wrinkles has an important psychological impact. Approved indications may vary by country.

Typical Duration of Effect

Individual results vary depending on the patient and treatment area.

Typical cosmetic outcomes include:

• Initial improvement within 2–3 days
• Maximum effect in approximately 1–2 weeks
• Results lasting approximately 3–5 months

Repeat treatment should only be performed when clinically appropriate.