BOCOUTURE® 100u (XEOMIN®) 1 vial

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Upper limb spasticity, cervical dystonia, and blepharospasm: the optimum dose, frequency, and number of injection sites in the treated muscle(s) should be based on severity and prior treatment response; individualize dosing for each patient:

• Upper Limb Spasticity in Adults: the recommended total dose is up to 400 Units no sooner than every 12 weeks
• Cervical Dystonia: recommended initial total dose is 120 Units per treatment session
• Blepharospasm: base initial dosing on previous dosing for onabotulinumtoxinA (Botox); if not known, the recommended starting dose is 1.25 Units-2.5 Units per injection site

Glabellar Lines: recommended dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each (two injections in each corrugator muscle and one injection in the procerus muscle; wait a minimum of three months before retreatment.

XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of adult patients with:

• upper limb spasticity
• cervical dystonia
• blepharospasm with onabotulinumtoxinA (Botox®) prior treatment
• temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity

BOCOUTURE is a medicine that contains the active substance Botulinum toxin type A which relaxes the injected muscles.

BOCOUTURE is used for temporary improvement of upper facial lines in adults under 65 years of age 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 and/or
• moderate to severe lateral periorbital lines seen at maximum smile and/or
• moderate to severe horizontal forehead lines seen at maximum contraction

• Reconstituted XEOMIN is intended for intramuscular injection only
• XEOMIN® is a shot (injection) that your doctor will give you.
• XEOMIN® is injected into your affected muscles.
• Use for only one injection session and for only one patient.
• Instructions are specific for 50 unit, 100 unit, and 200 unit vials.
• Your doctor may change your dose of XEOMIN® until you and your doctor find the best dose for you.
• Store in a refrigerator (2°C to 8°C) and use within 24 hours.

Contraindications:

• Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients.
• Infection at the proposed injection sites.
• Breathing problems, such as asthma or emphysema.
• History of swallowing problems or inhaling food or fluid into your lungs (aspiration).
• Plans to have surgery.
• Pregnancy or plans to become pregnant. It is not known if XEOMIN® can harm your unborn baby.
• Breastfeeding or plans to breastfeed. It is not known if XEOMIN® passes into breast milk.

After-care:

• XEOMIN® may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN®.
• If this happens, do not drive a car, operate machinery, or do other dangerous activities.