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Name of the medicinal product
BOCOUTURE 50 units powder for solution for injection

BOCOUTURE 100 units powder for solution for injection

2. Qualitative and quantitative composition
BOCOUTURE 50 units

One vial contains 50 units of Botulinum toxin type A (150 kD), free from complexing proteins*.

BOCOUTURE 100 units

One vial contains 100 units of Botulinum toxin type A (150 kD), free from complexing proteins*.

* Botulinumtoxin type A, purified from cultures of Clostridium Botulinum (Hall strain)

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Powder for solution for injection (powder for injection)

White powder

4. Clinical particulars
4.1 Therapeutic indications

BOCOUTURE 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

4.2 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 type A.

For detailed information regarding clinical studies with BOCOUTURE in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1.

General

BOCOUTURE may only be administered by physicians with suitable qualifications and the requisite experience in the application of Botulinum toxin type A.

Posology

Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines)

After reconstitution of BOCOUTURE a dose of 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.