Azzalure 125unit powder for solution for injection vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Botulinum toxin type A

Disponible desde:

Galderma (UK) Ltd

Código ATC:

M03AX01

Designación común internacional (DCI):

Botulinum toxin type A

Dosis:

125unit

formulario farmacéutico:

Powder for solution for injection

Vía de administración:

Intramuscular

clase:

No Controlled Drug Status

tipo de receta:

Caution - AMP level prescribing advised

Resumen del producto:

BNF: 04090300; GTIN: 5020465200222 05020465200307

Información para el usuario

Wrexham-Azzalure_125U-Leaflet-UK-Ireland-4-1.indd 1
08/11/2017 10:39
Wrexham-Azzalure_125U-Leaflet-UK-Ireland-4-1.indd 2
08/11/2017 10:39

Ficha técnica

OBJECT 1
AZZALURE
Summary of Product Characteristics Updated 17-Nov-2017 | Galderma
(U.K) Ltd
1. Name of the medicinal product
Azzalure, 10 Speywood units/0.05 ml, powder for solution for injection
2. Qualitative and quantitative composition
Botulinum toxin type A* 10 Speywood units **/0.05 ml of reconstituted
solution
Vial of 125 units
*_Clostridium botulinum_ toxin A haemagglutinin complex
**One Speywood unit (U) is defined as the median lethal peritoneal
dose in mice (LD50).
The Speywood units of Azzalure are specific to the preparation and are
not interchangeable with other
preparations of botulinum toxin.
For the full list of excipients see section 6.1.
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 physicians with appropriate
qualifications and expertise in this
treatment and having the required equipment.
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 ant