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TECHNICAL Medicine:

Presentations:

BOCOUTURE 50 units powder for solution for injection

Qualitative and quantitative composition

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

1 ml solution contains 40 units of Botulinum toxin type A (150 kD), free from complexing proteins when reconstituted in 1.25 ml.

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

For the full list of excipients, see section 6.1.

Pharmaceutical form

Powder for solution for injection

White powder

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

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 may only be administered by healthcare professionals with suitable qualifications and the requisite experience in the application of Botulinum toxin.

The medicine can only be obtained with a prescription.

FULL information on this medicine is available on the website of:

http://www.medicines.org.uk

Pharmacy del Pont can advise you how to buy Bocouture Botox Andorra. This medicine can only be obtained with a prescription.

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