BOCOUTURE 50IU is indicated for the temporary improvement in the appearance of upper facial lines in adults below 65 years when the severity of these lines has an important psychological impact for the patient:
• moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) and/or
• moderate to severe lateral periorbital lines seen at maximum smile (crow's feet lines) and/or
• moderate to severe horizontal forehead lines seen at maximum contraction
BOCOUTURE 50IU Posology and method of administration
Due to unit differences in the potency assay, unit doses for BOCOUTURE are not interchangeable with those for other preparations of Botulinum toxin.
For detailed information regarding clinical studies with BOCOUTURE in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1.
BOCOUTURE 50IU may only be administered by physcians with suitable qualifications and the requisite experience in the application of Botulinum toxin.
Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines)
After reconstitution of BOCOUTURE the recommended injection volume of 0.1 ml (4 units) is injected into each of the 5 injection sites: two injections in each corrugator muscle and one injection in the procerus muscle, which corresponds to a standard dose of 20 units. The dose may be increased by the physician to up to 30 units if required by the individual needs of the patients, with at least '3-months' interval between treatments.
BOCOUTURE 50IU An improvement in the vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) generally takes place within 2 to 3 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection.
Lateral Periorbital Lines seen at maximum smile (Crow's Feet Lines)
After reconstitution of BOCOUTURE the recommended injection volume of 0.1 ml (4 units) is injected bilaterally into each of the 3 injection sites. One injection of 0.1 ml is placed approximately 1 cm lateral from the bony orbital rim. The other two injections of 0.1 ml each should be placed approximately 1 cm above and below the area of the first injection