1. Name of the Medicinal Product

·         Azzalure, 125 Speywood units, powder for solution for injection

2. Qualitative and Quantitative Composition 

·         Botulinum toxin type A* Quantity corresponding to 125 Speywood units (U)** for one vial. 

·         *Clostridium botulinum toxin A haemagglutinin complex 

·         ** The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. 

3. Pharmaceutical Form 

·         Powder for solution for injection 

·         The powder is white. 

·          

4. Clinical Particulars 

4.1 Therapeutic Indications 

Azzalure is indicated for the temporary improvement in the appearance of moderate to severe: 

·         Glabellar lines (vertical lines between the eyebrows) seen at maximum frown and/or 

·         Lateral canthal lines (crow's feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. 

4.2 Posology and Method of Administration 

Posology: 

·         Botulinum toxin units are different depending on the medicinal products. The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. 

Paediatric Population: 

·         The safety and efficacy of Azzalure in individuals aged up to 18 years have not been established. The use of Azzalure is not recommended in subjects under 18 years. 

Method of Administration: 

·         Azzalure should only be administered by a specialised practitioner with appropriate qualifications and expertise in this treatment and having the required equipment, in accordance with national guidelines. 

·         Once reconstituted, Azzalure should only be used to treat a single patient, during a single session. 

·         For instructions on reconstitution of the medicinal product before administration, see section 6.6. 

·         Remove any make-up and disinfect the skin with a local antiseptic. 

·         Intramuscular injections should be performed using a sterile suitable gauge needle. 

·         The treatment interval depends on the individual patient's response after assessment. Treatment interval with Azzalure should not be more frequent than every three months. 

Recommended Injection Points for Glabellar Lines and Lateral Canthal Lines: 

·         Detailed instructions on injection points for both glabellar and lateral canthal lines are provided. 

4.3 Contraindications 

·         Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 

·         Presence of infection at the proposed injection sites 

·         Presence of myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis. 

4.4 Special Warnings and Precautions for Use 

·         Various precautions for use are listed, including the need to avoid injecting into blood vessels, the caution when used in patients with pre-existing neuromuscular disorders, the possibility of local and distant spread of toxin effect, and the risk of antibody formation. 

·         Detailed guidance is provided for facial anatomy assessment before administering Azzalure, and precautions for injection in the presence of inflammation or weakness. 

4.5 Interaction with Other Medicinal Products and Other Forms of Interaction 

·         Information on concomitant treatment with aminoglycosides and other agents interfering with neuromuscular transmission. 

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