国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Botulinum toxin type A
Galderma (UK) Ltd
M03AX01
Botulinum toxin type A
125unit
Powder for solution for injection
Intramuscular
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04090300; GTIN: 5020465200222 05020465200307
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 完全なドキュメントを読む
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 完全なドキュメントを読む